PRIMEADVANCED
Report
- Report Number
- 3004209178-2012-10284
- Event Type
- Injury
- Date Received
- November 15, 2012
- Report Date
- October 17, 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
PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. (B)(4).
PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS LEAD MIGRATION AFTER THE MOTOR VEHICLE ACCIDENT. THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION AND LESS THAN 50% THERAPY RELIEF. THE PATIENT'S SYSTEM WAS EXPLANTED AND NOT REPLACED. THE PATIENT'S STATUS WAS UNKNOWN.
IT WAS REPORTED THAT THE PATIENT WAS GETTING ONLY UNILATERAL COVERAGE FOR THEIR PAIN ("SHIFT TO THE RIGHT") FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). REPROGRAMMING OF THE INS DID NOT RESOLVE THE ISSUE. X-RAYS WERE TAKEN BUT THE RESULTS WERE NOT AVAILABLE. IT WAS ALSO REPORTED THAT THE PATIENT DID HAVE A MOTOR VEHICLE ACCIDENT (MVA), REPORTED AS BOTH (B)(6) 2012 AND "6 MONTHS AGO". IT WAS UNCLEAR AS TO THE IMPACT OF THE MVA(S) TO THE EVENT SINCE THE PATIENT DID NOT NOTICE A CHANGE IN THERAPY AT THOSE TIMES. THE PATIENT DID DESIRE A REVISION TO CONTINUE WITH THE THERAPY BUT IT WAS UNCLEAR AS TO THE PLAN OF CARE FROM THEIR PHYSICIAN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 |