FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2162542
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07428
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 19, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO A PATIENT INFECTION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST WAS MADE FOR PRODUCT RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | T165| (B)(4)| 0148| E110 |