ENDOTAK RELIANCE G
Report
- Report Number
- 2124215-2019-00597
- Event Type
- Injury
- Date Received
- January 22, 2019
- Date of Event
- December 13, 2018
- Report Date
- October 13, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526531194
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS LEAD WAS RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY IN TWO SEGMENTS, HAVING BEEN SEVERED DURING THE EXPLANT PROCEDURE. VISUAL EXAMINATION ALSO NOTED THAT THE HELIX MECHANISM WAS IN AN EXTENDED POSITION. DRIED BLOOD WAS NOTED AROUND THE HELIX. SUBSEQUENT TESTING, PERFORMED SEPARATELY ON EACH SEGMENT, DID NOT IDENTIFY ANY PRODUCT ABNORMALITIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. INSULATION DAMAGE WAS OBSERVED ~110-116 MM FROM THE TERMINAL END. INSULATION DAMAGE CHARACTERISTICS ARE CONSISTENT WITH LEAD-ON-LEAD ABRASION.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING, WITH NO PACING INHIBITION. THE LEAD WAS SUBSEQUENTLY REMOVED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS NOT BEEN RETURNED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING, WITH NO PACING INHIBITION. THE LEAD WAS SUBSEQUENTLY REMOVED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED, AND THIS REPORT WOULD BE UPDATED AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61974 | ENDOTAK RELIANCE G | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0185 | 305845 | 00802526531194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Life Threatening| H| R |