FDA Adverse Event
Injury
Summary report: N
PREVA DR
MDR report key: 2123818
·
Received June 14, 2011
Report
- Report Number
- 2647346-2011-00808
- Event Type
- Injury
- Date Received
- June 14, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S43
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
A LAWSUIT ALLEGED THAT THE PATIENT'S PACEMAKER WAS REPROGRAMMED AND THAT THE ADJUSTMENT CAUSED MUCH "PAIN AND SUFFERING PHYSICALLY, MENTALLY, AND EMOTIONALLY" AND THE PATIENT "LIVED IN FEAR" FOR SEVERAL WEEKS. IT WAS FURTHER REPORTED THAT THE PACEMAKER'S DECLINING BATTERY LIFE RESULTED IN SUDDEN PACEMAKER FAILURE. THE PACEMAKER WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREVA DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | 7088B | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Hospitalization| R | 5524M IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD |