FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3213777
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10082
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 16, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED AFTER POCKET CLOSURE. THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313975 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| L| R | E143| 4087| 0175| 0185 |