FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2181458
·
Received July 5, 2011
Report
- Report Number
- 3004209178-2011-05061
- Event Type
- Malfunction
- Date Received
- July 5, 2011
- Date of Event
- January 14, 2011
- Report Date
- June 8, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
HIGH IMPEDANCES WERE REPORTED. ELECTRODE 13 SHOWED IMPEDANCE READINGS >10,000 OHMS. THE IMPLANTED NEUROSTIMULATOR WAS REPROGRAMMED. TELEMETRY ISSUES WERE ALSO REPORTED. A PHYSICIAN MODE RECHARGE WAS PERFORMED AND THE PT WAS ABLE TO START RECHARGING HER SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | IMPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA033936N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB024186V| EXTENSION: MODEL 37081, LOT# NJB024188V| LEAD: MODEL 39565-30, LOT# N120317006| PROGRAMMER: MODEL 37742, LOT# NJD058866N| EXTERNAL DEVICE: MODEL 37761, LOT# C0214505| EXPLANTED:| EXPLANTED: |