FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1954048
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-24378
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, ALL PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT APPEARS TO HAVE AN INFECTION. THE PATIENT HAS A KNOWN ALLERGY TO ZINC AND THE SALES REPRESENTATIVE WAS ASKING IF THERE WAS ANY ZINC MATERIAL IN THE SHOCKING LEAD OR THE DEVICE. TECHNICAL SERVICES DISCUSSED IT WAS LIKELY NOT THE LEAD BECAUSE THE PATIENT ALREADY HAD THE LEAD IMPLANTED FOR SOME TIME. A MATERIAL CHANGE REQUEST WILL BE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | 4517| 4469| 0184| N118| H175 |