FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1944793
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19999
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- August 31, 2010
- Report Date
- October 8, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC SYSTEM HAD UNDERGONE A SYSTEM EXPLANT DUE TO A POCKET INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DUE TO THE PROCEDURE.
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 | 86 YR | Required Intervention | 4096| 0181| F110 |