FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 2151525
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06021
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 2, 2011
- Report Date
- April 13, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NINE DAYS LATER, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative · 1
THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE AND DEFIBRILLATION LEAD REMAIN IMPLANTED. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS DETECTED FOR HIGH OUT OF RANGE SHOCK IMPEDANCES. IT WAS REPORTED THAT THE PATIENT DOES NOT REGULARLY GET HIS DEVICE CHECKED SO THE CLINIC WAS GOING TO CONTACT HIM TO COME IN FOR TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| L| R | 1600| 0074| 0125| E102| 1763| 6937| T127| 1746 |