FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2230439
·
Received August 15, 2011
Report
- Report Number
- 3004209178-2011-06386
- Event Type
- Injury
- Date Received
- August 15, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 22, 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
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND AN OVERSTIMULATION SENSATION FOLLOWING A POSITION CHANGE. THE DEVICE WAS TURNED OFF USING THE PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization | EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3555-31, LOT# N289267| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA156478N| STIM ACCESSORY: MODEL 3550-39, LOT# N290006| PROGRAMMER: MODEL 37743, LOT# NKE170608N| LEAD: MODEL 3777, LOT# V714310004| EXPLANTED:| LEAD: MODEL 3777, LOT# V714310003 |