PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-00576
- Event Type
- Injury
- Date Received
- January 14, 2013
- Report Date
- December 21, 2012
- 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
(B)(4).
PRODUCT ID 748910, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 748910, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 7427, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 74002, LOT # N346042, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 3888, LOT # V487972, IMPLANTED: (B)(6) 2010, PRODUCT TYPE L EAD; PRODUCT ID 3888, LOT # V508993, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THE BATTERY OF THE IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETED IN ABOUT THREE MONTHS. THE BATTERY DEPLETION WAS SUSPECTED TO BE DUE TO A SHORT CIRCUIT ON A LEAD. THE INS WAS SET TO BE REPLACED WITH A RECHARGEABLE SYSTEM. NO IMPEDANCES WERE CHECKED DUE TO THE DEAD INS. A LOSS OF STIMULATION WAS ALSO REPORTED ON ONE SIDE OF THE PATIENT. THE SUSPECT LEAD WAS ALSO SET TO BE REPLACED WITH TWO NEW QUAD LEADS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
IT WAS LATER REPORTED THAT THE BATTERY HAD BEEN REPLACED AND THERAPY WAS PROGRAMMED AROUND THE SHORTED ELECTRODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19911 | 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 |