FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212527
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09078
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, OVERSENSING AND INAPPROPRIATE SHOCKS WERE NOTED. AS A RESULT, A REVISION PROCEDURE WAS SCHEDULED. PRIOR TO THE REVISION, THE SYSTEM WAS REVIEWED AND IT WAS CONFIRMED THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AT THE SUBCLAVIAN AREA. THE PACE/SENSE CHANNEL HAD BROKEN INSULATION. AS A RESULT, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312393 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | F102| 0185 |