FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3061783
·
Received April 16, 2013
Report
- Report Number
- 2124215-2013-06229
- Event Type
- Injury
- Date Received
- April 16, 2013
- Date of Event
- March 28, 2013
- Report Date
- March 28, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCES GREATER THAN 2000 OHMS AND INCREASED THRESHOLDS OF 4.0 VOLTS AT 1.5 MILLISECONDS. IT WAS SPECULATED THAT THE LEAD HAD FRACTURED. SURGICAL INTERVENTION WAS PERFORMED AND A FRACTURE WAS NOT ABLE TO BE CONFIRMED. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163027 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R | 0186| N160| 0296| 4470| 4548| 0185| H217 |