FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROMODULATION
MDR report key: 2081482
·
Received April 20, 2011
Report
- Report Number
- 3004209178-2011-02954
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 31, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WENT FOR A CT SCAN AND EXPERIENCED BATTERY ISSUES AFTERWARD. IT WAS STATED THE PT WENT IN TO THE CT SCAN WITH A FULLY-CHARGED BATTERY, AND AFTER THE SCAN THE BATTERY LEVEL WAS DEPLETED AND THE PT LOST THERAPEUTIC EFFECT. IT WAS STATED THIS HAS HAPPENED IN THE PAST TO THE PT, BUT NO OTHER DETAILS WERE GIVEN. THE PT ALSO REPORTED TROUBLE COMMUNICATING WITH THE DEVICE, AND AN OVERDISCHARGE WAS SUSPECTED. THE PT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROMODULATION | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT # V002505| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # UNK| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT # NJD021295N| LEAD: MODEL 3777, LOT # V002505| EXPLANTED:| IMPLANTED: |