FDA Adverse Event
Injury
Summary report: N
RESTORE SENSOR
MDR report key: 3242272
·
Received July 23, 2013
Report
- Report Number
- 3004209178-2013-12136
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD A REVISION TO MOVE HER IMPLANTABLE NEUROSTIMULATOR (INS) LOWER. THE PATIENT¿S INS WAS DEPLETED, SO THEY COULD NOT COMMUNICATE WITH THE PATIENT PROGRAMMER OR PHYSICIAN PROGRAMMER. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS GETTING GOOD COUPLING NOW WHEN CHARGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342891 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR |