FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3951053
·
Received July 22, 2014
Report
- Report Number
- 2124215-2014-10704
- Event Type
- Malfunction
- Date Received
- July 22, 2014
- Date of Event
- March 3, 2013
- Report Date
- April 8, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION NOTED INSULATION DAMAGE EXPOSING THE CONDUCTOR COIL 263-270 MM FROM THE TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF DAMAGE IT WAS LIKELY THIS WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION. LEAD-ON-LEAD ABRASION WAS ALSO NOTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LARGE NUMBER OF SHOCKS DUE TO OVERSENSING. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428266 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | 4096| 0181| 4542| P107| H240 |