FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1162801
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05780
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 21, 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
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS NOT GETTING THERAPY ON HIS LEFT SIDE; THE PATIENT WAS GETTING THERAPEUTIC BENEFIT ON HIS RIGHT SIDE. IMPEDANCES WERE CHECKED. IMPEDANCES ON ELECTRODES 4-7 WERE FOUND TO BE <50 OHMS. THE LEAD/EXTENSION WAS REVISED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HEALTH CARE PROFESSIONAL, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ACCESSORY MODEL 37752 LOT# NKA116261N IMPLANTED| PROGRAMMER MODEL 37743 LOT# NKE105746N IMPLANTED| EXTENSION MODEL 37082 LOT# NKB011908N IMPLANTED| LEAD MODEL 3998 LOT# J0444256V IMPLANTED:| EXPLANTED| EXPLANTED| EXPLANTED| EXPLANTED |