FDA Adverse Event
Injury
Summary report: N
INSYNC
MDR report key: 2812133
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02340
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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 EXPERIENCED SHORTNESS OF BREATH AND FATIGUE. IT WAS NOTED THAT THE PACEMAKER HAD BEEN WIRED INCORRECTLY AND PROVIDED NO BENEFIT TO THE PATIENT'S HEALTH. THE PATIENT WAS NOT AWARE OF "ALL DEFECTS IN THE FUNCTION AND PLACEMENT OF THE PACEMAKER" UNTIL THE PATIENT FAILED A MANDATED EMPLOYMENT PHYSICAL. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | 8040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | 4068 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD |