ENDOTAK RELIANCE S
Report
- Report Number
- 2124215-2022-48562
- Event Type
- Injury
- Date Received
- November 22, 2022
- Date of Event
- November 3, 2022
- Report Date
- January 17, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526531118
- PMA / PMN Number
- P910073/S039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER/OUTER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.
CORRECTION, H6 CODE ADDED. F1907 UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER/OUTER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.
IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR (RV) LEAD EXTRACTION, THIS RV LEAD WAS AN ATTEMPT IMPLANT. THE PHYSICIAN NOTICED THAT DURING THIS LEAD IMPLANTATION THE LEAD WENT EXTRAVASCULAR AND REMOVED IT IMMEDIATELY. FOLLOWING, THE PATIENT DEVELOPED HYPOTENSION, PERICARDIAL EFFUSION AND CARDIAC ARREST. THE PHYSICIAN PERFORMED A HEART OPEN SURGERY, AND IT WAS NOTED THAT THE OLD RV LEAD WAS EXTRAVASCULAR PRIOR TO REMOVAL WITH THE LASER. THE PATIENT RECEIVED A NEW SYSTEM AND WAS DISCHARGED FROM THE HOSPITAL FOR ROUTINE FOLLOW UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR (RV) LEAD EXTRACTION, THIS RV LEAD WAS AN ATTEMPT IMPLANT. THE PHYSICIAN NOTICED THAT DURING THIS LEAD IMPLANTATION THE LEAD WENT EXTRAVASCULAR AND REMOVED IT IMMEDIATELY. FOLLOWING, THE PATIENT DEVELOPED HYPOTENSION, PERICARDIAL EFFUSION AND CARDIAC ARREST. THE PHYSICIAN PERFORMED A HEART OPEN SURGERY, AND IT WAS NOTED THAT THE OLD RV LEAD WAS EXTRAVASCULAR PRIOR TO REMOVAL WITH THE LASER. THE PATIENT RECEIVED A NEW SYSTEM AND WAS DISCHARGED FROM THE HOSPITAL FOR ROUTINE FOLLOW UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR (RV) LEAD EXTRACTION, THIS RV LEAD WAS AN ATTEMPT IMPLANT. THE PHYSICIAN NOTICED THAT DURING THIS LEAD IMPLANTATION THE LEAD WENT EXTRAVASCULAR AND REMOVED IT IMMEDIATELY. FOLLOWING, THE PATIENT DEVELOPED HYPOTENSION, PERICARDIAL EFFUSION AND CARDIAC ARREST. THE PHYSICIAN PERFORMED A HEART OPEN SURGERY, AND IT WAS NOTED THAT THE OLD RV LEAD WAS EXTRAVASCULAR PRIOR TO REMOVAL WITH THE LASER. THE PATIENT RECEIVED A NEW SYSTEM AND WAS DISCHARGED FROM THE HOSPITAL FOR ROUTINE FOLLOW UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247647 | ENDOTAK RELIANCE S | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0138 | 303028 | 00802526531118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention| L| H |