FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 2863867
·
Received December 10, 2012
Report
- Report Number
- 3004209178-2012-11338
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Report Date
- November 15, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT'S STIMULATION "DOESN'T WORK." IT WAS NOTED THAT THE PATIENT HAD ALZHEIMER'S DISEASE. THE REPORTER WAS UNSURE IF THE PATIENT WAS NOT USING HIS DEVICE BECAUSE HE WAS PAIN FREE OR IF HE COULD NOT REMEMBER DUE TO ALZHEIMER'S DISEASE. IT WAS NOTED THAT THE PATIENT WAS NOT ASKING FOR PAIN MEDICATION. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED A SUPPLEMENTAL 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 |