FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3830911
·
Received May 23, 2014
Report
- Report Number
- 3004209178-2014-09596
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 4, 2014
- 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
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-33, LOT# V013824, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED, THE PATIENT WAS GOING TO THE BATHROOM MORE FREQUENTLY. IT WAS REPORTED, THE SYMPTOMS OCCURRED AFTER A FALL. IT WAS NOTED, THE PATIENT COLLAPSED TO THE FLOOR IN A TWISTED WAY UNRELATED TO THERAPY. IT WAS REPORTED, THE PATIENT¿S PROGRAMMER WAS NOT WORKING AND THEY COULD NOT COMMUNICATE WITH THEIR DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307949 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR |