FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 4802627
·
Received May 28, 2015
Report
- Report Number
- 3004209178-2015-09847
- Event Type
- Injury
- Date Received
- May 28, 2015
- Report Date
- May 6, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377860, LOT# V014980, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4) IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377860, LOT# V013243, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN EXPLANT. THE THERAPY STOPPED HELPING THE PATIENT¿S PAIN SO THEY WANTED TO TAKE IT OUT. THE PATIENT OUTCOME AFTER EXPLANT WAS NOT KNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347142 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Required Intervention |