FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 4585114
·
Received March 10, 2015
Report
- Report Number
- 3004209178-2015-04440
- Event Type
- Malfunction
- Date Received
- March 10, 2015
- Report Date
- February 13, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-28, LOT# V952224, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DID HAVE CONCERNS WITH THEIR DEVICE OR THERAPY BECAUSE THEIR DEVICE ONLY LASTED THREE YEARS, BUT THEY WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT ALSO NOTED THAT THEY DID NOT HAVE CONCERNS AND RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. NO INTERVENTIONS OR OUTCOME WERE REPORTED RELATED TO THIS EVENT. ADDITIONAL FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163669 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR |