FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1922922
·
Received November 9, 2010
Report
- Report Number
- 3004209178-2010-09090
- Event Type
- Malfunction
- Date Received
- November 9, 2010
- Date of Event
- May 1, 2010
- Report Date
- October 19, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION, PAINFUL STIMULATION IN HER RIGHT LEG, AND PAIN WHILE URINATING. IT WAS STATED THE PT "FELL AT A WATERPARK" IN (B)(6)2010, AND AFTER COULD FEEL STIMULATION WHETHER THE DEVICE WAS ON OR OFF. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. REFERENCE MFR REPORT # 3004209178-2010-09092.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | IMPLANTABLE NEURO STIMULATOR: MODEL 3058,| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD076716N| LOT # NJY110244H| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT # V280397| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD055231N| EXPLANTED:| LEAD: MODEL 3093, LOT # V056304| EXPLANTED:| EXPLANTED:| EXPLANTED: |