FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 2945671
·
Received February 6, 2013
Report
- Report Number
- 3004209178-2013-01356
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 22, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3998, LOT# LB2950, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S INS AND EXTENSION WERE REPLACED. FOLLOWING THE REPLACEMENT IMPEDANCES OVER 40,000 OHMS WERE SEEN ON CONTACT 3. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING GREAT AND ALL IMPEDANCES WERE GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49925 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR |