FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2244054
·
Received August 24, 2011
Report
- Report Number
- 3007566237-2011-06774
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 8, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELT LIKE SHE HAD A SEIZURE AFTER SHE GOT HOME FROM THE IMPLANT OF HER REPLACEMENT DEVICE IN (B)(6) 2011. THE SYMPTOMS WERE LIKELY SHOCKING OR JOLTING. SHE HAD STRONG STIMULATION DOWN HER LEG AND INTO HER TOE AND STIMULATION IN THE VAGINAL AREA THAT WAS VERY UNCOMFORTABLE. THE PATIENT TURNED THE STIMULATION DOWN AND NOW BELIEVES THAT IT MAY BE TURNED OFF. A MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THAT HER DEVICE WAS OFF. THE REPRESENTATIVE TURNED THE DEVICE ON, SHOWED THE PATIENT HOW TO USE THE PROGRAMMER AND REPORTED THAT "ALL WAS TAKEN CARE OF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC NEUROMODULATION | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |