Boston Scientific CRM's data span the complete product performance reporting continuum. We make every effort to capture customer experiences with our products and publish data consisting of reported observations as well as returned product analysis findings. Like others in the industry, our report depicts data gathered during active product service, but unlike others in the industry, we depict data gathered before and during the implant procedure, as well as during the explant procedure. Figure 1 illustrates how Boston Scientific report elements map to time periods in the product experience continuum. Inclusion criteria for specific report elements are described in more detail below.
Figure 1.
Before/During Implant Procedure
Worldwide Confirmed Malfunctions
This section of the report depicts the number of product malfunctions that occurred worldwide either before implant (prior to opening the sterile product packaging) or during implant (once the sterile product packaging has been opened). The product in question must be returned to Boston Scientific and confirmed through laboratory analysis to have operated or exhibited a problem outside the specified performance limits established by Boston Scientific. Damage incurred during shipping/transit or due to external factors warned against in labeling (e.g., radiation) is not reported as a device malfunction.
First Month of Lead Implant
U.S. Reports of Acute Lead Observations
A small proportion of leads involved in a complication are explanted and returned for laboratory analysis. Because acute lead performance contributes to overall clinical experience, Boston Scientific provides a summary of U.S. reports of lead observations occurring in the first month of service. Acute lead performance may be subject to a number of factors, including patient-specific clinical conditions and/or varying implant conditions/techniques. To be included in this summary of observations, a lead must first be successfully implanted. These reports may or may not have resulted in clinical action and/or product return to Boston Scientific. Multiple observations are possible for any given lead.
While Implanted
U.S. Survival Probability
Data and Worldwide Confirmed Malfunction Details
These data span the entire duration of active product service. Data are provided for CRT devices, ICDs, and Pacemakers, as well as CRT, defibrillation, and pacing leads. Please reference the Statistical Methodology section for a complete discussion of reporting methodology and inclusion criteria.
During Explant/Replacement
Procedure
Worldwide Confirmed Malfunctions
This section of the report depicts the number of product malfunctions that occurred worldwide during the explant procedure (while the explant surgical field is still open). The product must be returned to Boston Scientific and confirmed through laboratory analysis to have operated or exhibited a problem outside the specified performance limits established by Boston Scientific.
Reasons for device explant or out of service are provided here. Reasons may be due to normal battery depletion, device upgrade, complication related to another system component or clinical conditions such as infection, device malfunction (which includes devices under advisory that have experienced a malfunction), or "other", a category consisting of patient death, prophylactic device explant, elective replacement, general product dissatisfaction, other observation/complication, unspecified, or unknown. Although a device may be indicated by a healthcare provider to have been taken out of service for more than one reason, the table indicates only one reason per device.
