FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 2930721
·
Received January 28, 2013
Report
- Report Number
- 3004209178-2013-01002
- Event Type
- Injury
- Date Received
- January 28, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 9, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED CENTRAL CANAL STENOSIS. A CT SCAN REVEALED THAT THE CENTRAL CANAL STENOSIS WAS LOCATED AT THE PADDLE LEAD. SURGICAL DECOMPRESSION WAS PERFORMED AND THE PADDLE LEAD WAS REPLACED. THE PATIENT'S SYMPTOM WAS LEG WEAKNESS. THE PATIENT WAS DESCRIBED AS ALIVE WITH INJURY; LEG WEAKNESS. FURTHER INFORMATION WAS REQUESTED. IF MORE INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED 'WITHOUT ANY PROBLEMS' AND THE STIMULATION WAS 'SATISFACTORY.'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36460 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Required Intervention |