FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1844585
·
Received September 23, 2010
Report
- Report Number
- 3004209178-2010-07219
- Event Type
- Injury
- Date Received
- September 23, 2010
- Date of Event
- January 1, 2010
- Report Date
- April 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A SUSPECTED DEVICE OVER DISCHARGE. PT COMPLIANCE WAS THE PRIMARY REASON FOR OVER DISCHARGE. PT SAID THE DEVICE NEVER PROVIDED THERAPEUTIC EFFECT. THE DEVICE WAS EXPLANTED ON (B)(6) 2010. THE DEVICE WAS SUPPOSED TO RELIEVE HIP AND BACK PAIN BUT THOSE AREAS WERE NEVER TARGETED WITH MULTIPLE REPROGRAMMING SESSIONS. ADD'L INFO 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 RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | ACCESSORY: MODEL RECHARGER, LOT#: UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3999, LOT#: V003285| EXPLANTED:| PROGRAMMER: 37742, LOT#: NJD021905N| EXPLANTED:| IMPLANTED: |