FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2230552
·
Received August 12, 2011
Report
- Report Number
- 3004209178-2011-06293
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- September 7, 2007
- Report Date
- July 21, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A BATTERY ONLY REVISION THE PT WAS UNABLE TO FEEL STIMULATION. THERE WAS NO BURNING, JOLTING OR SHOCKING AND IMPEDANCES WERE ALL WITHIN RANGE. IMAGING AND PALPATION WERE SUGGESTED AS TWO POSSIBLE INTERVENTIONS. ADD'L INFO RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT THE PT WOULD BE SCHEDULED FOR LEAD REVISION. THE LEAD AND EXTENSION WERE REPLACED, AND THE HCP REPORTED THAT THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention | LEAD: MODEL 3487A, LOT# L57989| EXPLANTED:| IMPLANTED: |