FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2323416
·
Received November 3, 2011
Report
- Report Number
- 3004209178-2011-09046
- Event Type
- Malfunction
- Date Received
- November 3, 2011
- Date of Event
- September 29, 2011
- Report Date
- October 13, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- 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
Additional Manufacturer Narrative · 1
PROGRAMMER MODEL 3037 SERIAL# (B)(4); LEAD MODEL 3093-28 LOT# V192503 IMPLANTED: (B)(6) 2009 EXPLANTED: UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHEN STIMULATION WAS ON AND OFF, EVEN WHEN STIMULATION WAS TURNED DOWN. THIS STARTED AROUND THE LEAD LOCATION AND SPREAD DOWN TO THE LEFT FOOT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT - IT STARTED TWO WEEKS AGO OUT OF THE BLUE. THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN SCHEDULED FOR (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00042 YR |