FDA Adverse Event
Malfunction
Summary report: N
RESTORE SENSOR
MDR report key: 2881845
·
Received December 20, 2012
Report
- Report Number
- 3004209178-2012-12083
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Report Date
- November 30, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE OR BOTH OF A PATIENT'S LEADS HAD MIGRATED, AND X-RAYS CONFIRMED THE MIGRATION. RE-PROGRAMMING WAS DONE AND THE PATIENT WAS REPORTED TO BE GETTING THERAPY IN THE "CORRECT" LOCATION. IT WAS NOTED THAT THE LEAD WAS ONLY THREE WEEKS OLD AND MAY NEED MORE TIME TO HEAL IN PLACE. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 |