RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-20519
- Event Type
- Malfunction
- Date Received
- November 12, 2013
- Report Date
- November 4, 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
- NE, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37754, SERIAL #: (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 387445, LOT# V970533, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 387445, LOT# V970533, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING DEVICE. (B)(4).
IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING ELECTROMAGNETIC INTERFERENCE (EMI) WITH HER IMPLANTABLE NEUROSTIMULATOR (INS) FROM PIZZA OVENS AT HER WORKPLACE THAT ¿PUT OFF A LOT OF EXTRA ENERGY.¿ WHEN THE PATIENT WAS NEAR THE OVENS, SHE REPORTEDLY ¿GOT A LITTLE RAMPED UP FROM IT, IT MADE HER FEEL GIDDY.¿ THE PATIENT REPORTEDLY ¿FELT FINE¿ WHEN SHE LEFT THE OVEN AREA, BUT WHEN SHE MOVED PAST THE OVENS WITH HER LOWER BACK WHERE HER DEVICE WAS IMPLANTED, ¿SHE FELT EXTRA STIMULATION, LIKE SHE BUMPED IT UP 2 OR 3 NOTCHES.¿ IT WAS NOTED THAT THIS HAD BEEN GOING ON SINCE (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585743 | 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 | 00027 YR |