FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE G
MDR report key: 15442921
·
Received September 17, 2022
Report
- Report Number
- 2124215-2022-36569
- Event Type
- Injury
- Date Received
- September 17, 2022
- Date of Event
- September 6, 2021
- Report Date
- September 16, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526531194
- PMA / PMN Number
- P910073/S043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO CONSISTENTLY HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS FROM 110-139 OHMS. THE CAUSE OF THE OBSERVED OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS WAS NOT CONCLUSIVELY DETERMINED, HOWEVER SHOCK IMPEDANCE TRENDS WERE CHARACTERIZED BY A GRADUAL RISE IN MEASUREMENTS. THE LEAD REVISION AND SUBSEQUENT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125810 | ENDOTAK RELIANCE G | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | 0185 | 344313 | 00802526531194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Hospitalization| R |