FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1083598
·
Received July 29, 2008
Report
- Report Number
- 3004209178-2008-04475
- Event Type
- Malfunction
- Date Received
- July 29, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 2, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IMPEDANCE READINGS OF >10,000 OHMS WERE FOUND. THE ONLY COMBINATIONS IN THE NORMAL RANGE WERE 2-3, 2-9, AND 3-9 WHICH DID PROVIDE STIMULATION FOR THE PT, BUT THE STIMULATION WAS IN THE WRONG LOCATION. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP 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 | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT#NKC011448N| EXTENSION MODEL 37083 LOT#NKC011113N| ACCESSORY MODEL 37752 LOT#NKA019626N| PROGRAMMER MODEL 37742 LOT#NJD043812N| IMPLANTED| LEAD MODEL 3998 LOT#V022880| EXPLANTED| IMPLANTED |