FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 3102211
·
Received May 9, 2013
Report
- Report Number
- 3004209178-2013-07412
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Report Date
- April 15, 2013
- 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS STATED THAT APPROXIMATELY 1.5 YEARS AGO, THE PATIENT WALKED THROUGH A LIBRARY SECURITY SYSTEM AND HIS ARMS AND LEGS ¿FLIPPED AROUND FOR 5 DAYS.¿ THE PATIENT WAS TO SCHEDULE A FOLLOW-UP APPOINTMENT WITH HIS MANAGING PHYSICIAN AND THE MANUFACTURER REPRESENTATIVE. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204565 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |