FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2061851
·
Received April 4, 2011
Report
- Report Number
- 3007566237-2011-02559
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION UP AND DOWN THEIR RIGHT LEG. THERE WAS NO ACCIDENT OR INCIDENT ASSOCIATED WITH THIS EVENT. THE PATIENT TURNED THE STIMULATION DOWN FROM 2.6 VOLTS TO 2.3 VOLTS WAS REPORTED AS NOW DOING OKAY. WE WERE UNABLE TO FOLLOW-UP ON THIS EVENT WITH THE CONTACT INFORMATION RECEIVED, HENCE NO ADDITIONAL INFORMATION WAS OBTAINED.
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 |