FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1083109
·
Received July 24, 2008
Report
- Report Number
- 3004209178-2008-04344
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 27, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ALL ELECTRODE IMPEDANCES WERE HIGH, READING >40,000 OHMS. THE IMPEDANCES WERE NOT CHECKED AT IMPLANT. THE HEALTH CARE PROFESSIONAL WAS PLANNING TO DO A REVISION TO CHECK THE CONNECTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 | EXPLANTED| LEAD MODEL 3777-45 LOT# V052297028| LEAD MODEL 3777-45 LOT# V059755003| EXPLANTED| PROGRAMMER MODEL 37743 LOT# NKE110870N| EXTENSION MODEL- 37081 LOT# NJB026979V| EXTENSION MODEL- 37081 LOT# NJB031847V| ACCESSORY MODEL 37752 LOT# NKA114812N| EXPLANTED| EXPLANTED |