FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1853905
·
Received September 7, 2010
Report
- Report Number
- 3007566237-2010-06817
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- January 1, 2010
- Report Date
- August 11, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON, AND USING AN ELECTRIC WEEDER, THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC NEUROMODULATION | IPG URO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |