FDA Adverse Event
Death
Summary report: N
ENDOTAK DSP
MDR report key: 1980428
·
Received February 7, 2011
Report
- Report Number
- 2124215-2011-02257
- Event Type
- Death
- Date Received
- February 7, 2011
- Date of Event
- October 13, 2010
- Report Date
- October 13, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- 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 DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE AND SHOCK CHANNEL RESULTING IN PACING INHIBITION. NO ASYSTOLE WAS OBSERVED AS THE PATIENT HAD AN UNDERLYING SINUS RHYTHM. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. THE PATIENT EXPIRED DUE TO COMPLICATIONS RESULTING FROM THE LEAD EXTRACTION. NO FURTHER INFORMATION WAS AVAILABLE.
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 | 86 YR | Death | H135| 4087| 0125| 4470| 1388T| 4512| 1823| H175| 5592 |