FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 3031508
·
Received April 2, 2013
Report
- Report Number
- 3004209178-2013-04509
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- March 12, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY. (B)(4) - FINAL DEVICE ANALYSIS OF THE IMPLANTALBLE NEUROSTIMULATOR (INS) FOUND NO ANOMALIES. FINAL DEVICE ANALYSIS OF THE BOOT FOUND NO ANOMALIES.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED DUE TO ISSUES WITH BATTERY LOCATION IN LEFT BUTTOCK REGION. IT WAS STATED THAT THE PATIENT REQUESTED THE REMOVAL FOR REPOSITIONING ON THE RIGHT. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133757 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |