FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1884886
·
Received October 20, 2010
Report
- Report Number
- 3004209178-2010-08147
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OVERDISCHARGED DEVICE WAS SUSPECTED. A POWER ON RESET CONDITION WAS INDICATED. IT WAS RECOMMENDED THAT PHYSICIAN MODE RECHARGES BE PERFORMED. THE PT STATED HE HAD BEEN ABLE TO RECHARGE HIS DEVICE SINCE HE HAD A PROCEDURE PERFORMED 2 TO 3 MONTHS AGO, IN WHICH THEY "PUT NEEDLES IN HIS BACK." THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT 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 | 44 YR | EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD039025N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB023168V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB023596V| LEAD: MODEL 39565-30, LOT# N125749004| ACCESSORY: MODEL 37752, LOT# NKA027021N| EXPLANTED: |