FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3287955
·
Received August 14, 2013
Report
- Report Number
- 3004209178-2013-14634
- Event Type
- Malfunction
- Date Received
- August 14, 2013
- Report Date
- July 19, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID 3093-28, LOT# V183293, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PASSED THROUGH SECURITY SCREENERS AT A RETAIL STORE AND EXPERIENCED A SURGE IN STIMULATION. IT WAS NOTED THAT THE IMPLANT WAS OFF AFTER LEAVING THE STORE AND THE PATIENT WET THEMSELVES. IT WAS NOTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THE DEVICE OR THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389932 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00024 YR |