FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 10701376
·
Received October 19, 2020
Report
- Report Number
- 3004209178-2020-18234
- Event Type
- Malfunction
- Date Received
- October 19, 2020
- Date of Event
- January 1, 2008
- Report Date
- October 19, 2020
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998 LOT#: V062321, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3998, SERIAL/LOT #: (B)(4), UBD: 12-OCT-2011, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT IN 2008, THEY HAD ELECTROCAUTERY DONE, WHICH RESULTED IN THE INS AND THE LEADS GETTING BURNT. THEY EXPLAINED THAT THEY HAD FORGOTTEN TO TURN OFF THE INS BEFORE THE ELECTROCAUTERY WAS PERFORMED. NO SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1162803 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |