INTERSTIM II
Report
- Report Number
- 3004209178-2013-08435
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Report Date
- May 10, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 889-28, LOT# V931559, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.
IT WAS REPORTED THAT STIMULATION PAINFUL, WAS A LITTLE TOO STRONG FOR HER WHEN SHE WOULD WAKE UP IN THE MORNING AND DURING THE DAY. IT SEEMED LIKE PAIN / STIM GOES ON OR OFF AT CERTAIN TIME. STIMULATION WAS INTERMITTENT. SYMPTOMS STARTED ABOUT 2 WEEKS AGO AND WHEN SHE GOT UP FROM BED. THE PATIENT DID NOT HAVE PAIN OR STRONG STIM DURING THE NIGHT. THE PATIENT WOULD SLEEP ALL NIGHT. IT WAS PAINFUL AND UNCOMFORTABLE AND SEEMED TO BE GETTING WORSE. WHEN WALKING IT WENT AWAY. THE PATIENT STARTED EXERCISING RECENTLY. THE PATIENT WAS NERVOUS ABOUT USING THE PATIENT PROGRAMMER AND DID NOT HAVE ANYONE TO HELP HER. THE PATIENT ADJUSTED STIM FROM PROGRAM 2 @ 1.3V TO PROGRAM 2 @ 1.2V. THE PATIENT PLANNED TO TRY SETTING TO SEE IF IT WOULD HELP HER. THE PATIENT HAD CONCERNS ABOUT CHANGING STIM IT AND STOPPING THERAPY RELIEF. THE PATIENT PLANNED TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241015 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR |