FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 2173689
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10922
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 17, 2011
- Report Date
- June 17, 2011
- Manufacturer
- HISTORICAL PUERTO RICO
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 PRODUCT WAS PART OF A PLANNED SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | HISTORICAL PUERTO RICO | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | 4285| E102| 4269| 1762| 1232| 1130| 1860| 0125| T177 |