RESTORE
Report
- Report Number
- 3004209178-2013-07914
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- February 1, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID: 377775 LOT# J0555087V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 377775 LOT# J0555087V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37742 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
(B)(4).
FINAL ANALYSIS OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE INS HAD ¿REDUCED CAPACITY DUE TO OVERDISCHARGE.¿
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
IT WAS REPORTED, THE PATIENT PREVIOUSLY HAD DIFFICULTY WITH RECHARGING AND THEN DID NOT NEED TO USE HIS STIMULATOR DUE TO DECREASED PAIN. THE PATIENT¿S PAIN RETURNED SO HE OPTED TO REPLACE THE BATTERY. IT WAS NOTED BATTERY DEPLETION WAS NOT NORMAL. THE PATIENT RECOVERED WITHOUT SEQUELA.
IT WAS NOTED THE PATIENT HAD "NOT RECHARGED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222761 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |