FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 3802903
·
Received May 9, 2014
Report
- Report Number
- 3004209178-2014-08811
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Report Date
- April 24, 2014
- 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NEVER THERAPEUTIC EFFECT. THE PATIENT NOTED ¿PROBLEMS¿ WITH THE FIRST STIMULATOR. IT WAS NOTED THAT IT WORKED FOR THE PATIENT FOR ONLY THE FIRST WEEK AND THEN STOPPED PROVIDING THE PAIN RELIEF. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280981 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00046 YR |