FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 3160024
·
Received June 10, 2013
Report
- Report Number
- 3004209178-2013-10047
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 20, 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
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT STOPPED FEELING STIMULATION THE MORNING OF REPORT AND HAD BEEN IN PAIN. IT WAS ALSO STATED THE PATIENT HAD A ¿CALL YOU DR¿ ICON THE MORNING OF REPORT AS WELL. REPORTEDLY, USING THE PATIENT PROGRAMMER, THE PATIENT WAS TURNING ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT WAS NOT RESPONDING.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THAT THE BATTERY WAS GOING LOW. IF MORE INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259446 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR |