FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2173329
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-11052
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 14, 2011
- Report Date
- July 29, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD WAS NOTED TO HAVE PERFORATED THE PATIENT'S PERICARDIUM. THE PHYSICIAN ELECTED TO IMPLANT A NEW LEAD APPROXIMATELY ONE MONTH LATER.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS PROVIDED THAT THE PERFORATION HAD BEEN CONFIRMED VIA ECHOCARDIOGRAPHY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Hospitalization| L| R | E102| 0181 |