FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 3023481
·
Received March 27, 2013
Report
- Report Number
- 3007566237-2013-00905
- Event Type
- Injury
- Date Received
- March 27, 2013
- Report Date
- March 8, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S DEVICE WAS REPLACED DUE TO PAIN AT THE DEVICE SITE, LOCATED ON THE PATIENT'S BOTTOM. IT WAS ALSO REPORTED THE BATTERY WAS AT ITS END OF LIFE AND THE REPLACEMENT DEVICE WAS INSTEAD IMPLANTED IN THE PATIENT'S ABDOMEN. IT WAS REPORTED THE PATIENT RECOVERED WITH NO INJURY OR ADVERSE EVENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COMPLAINT DIDN'T CONCERN THE BATTERY DEPLETION AND IT WAS NOTED THAT THE VOLTAGE WAS HIGH FOR THE PATIENT. THE REPORTER STATED THAT THE PATIENT WAS ALL RIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126984 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |