FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2102689
·
Received May 19, 2011
Report
- Report Number
- 3004209178-2011-03660
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 21, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S DEVICE WAS OVERDISCHARGED AND WAS IN A POWER ON RESET CONDITION. THE PT ALSO SUSPECTED A PROBLEM WITH HIS EXTERNAL RECHARGER. THIS WAS THE THIRD OVERDISCHARGE AND A REPLACEMENT OF THE NEUROSTIMULATOR WAS SCHEDULED. NO PT SYMPTOMS WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | ACCESSORY: MODEL 37752, LOT# NKA114791N| PROGRAMMER: MODEL 37743, LOT# NKE103432N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V123536024 |