FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3973822
·
Received August 1, 2014
Report
- Report Number
- 3004209178-2014-13855
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- May 29, 2014
- Report Date
- July 10, 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
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 093-33, LOT# V581929, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD JOLTS TO THEIR VAGINAL AREA. IT WAS NOTED REPROGRAMMING OCCURRED ON (B)(6) 2014. IT WAS NOTED ONE DAY PRIOR TO REPROGRAMMING, THE STIMULATION HAD TURNED OFF ON ITS OWN AND THEY DIDN¿T TURN IT BACK ON UNTIL THE DAY OF REPROGRAMMING. IT WAS NOTED THEY HAD A TEMPORARY DISCONTINUATION OF STIMULATION. THEY HAD AN UNDESIRABLE CHANGE IN STIMULATION AND THE PATIENT RECOVERED WITHOUT SEQUELAE 9 DAYS PRIOR TO REPORT. (B)(6) 2014 CLINICAL UPDATE: NO NEW INFORMATION, MEDDRA CODES UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451191 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR |