FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3213631
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10817
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 3, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ANALYSIS SHOWED THAT THERE WAS A TRILUMEN INSULATION DAMAGE. THIS TYPE OF DAMAGE MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION. NO COIL FRACTURE WAS OBSERVED. LEAD PASSED CONTINUITY TEST.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AND EXHIBITED VARYING CHANGES IN IMPEDANCE. IN ADDITION, THIS LEAD EMITTED NOISE, HAD DECREASED AMPLITUDE AND DELIVERED INAPPROPRIATE SHOCKS. THIS RV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313505 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| L| R | 4136| 4555| 5071| 0185| 4543| H170| 4087| N119 |