FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1063672
·
Received June 19, 2008
Report
- Report Number
- 3004209178-2008-03359
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- April 1, 2008
- Report Date
- May 21, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001/S74
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT EXPERIENCED NO STIMULATION. IMPEDANCE READINGS WERE GREATER THAN 3600 OHMS. THE IMPLANTABLE PULSE GENERATOR NEEDED MORE RECHARGING THAN EXPECTED. THE HCP DETERMINED THE LEAD HAD AN ISSUE. LEAD REVISION OR REPLACEMENT WAS BEING DISCUSSED AS AN OPTION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOT# NAT109047H IMPLANTED:| EXTENSION MODEL 37083 LOT# NKC003649N IMPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD011549N| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7425| EXPLANTED:| EXPLANTED:| LEAD MODEL# 3998 |