FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1885171
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08358
- Event Type
- Injury
- Date Received
- October 25, 2010
- Date of Event
- September 27, 2010
- Report Date
- September 27, 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
- TN, 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 THERE WAS A SHOCKING OR JOLTING SENSATION. IT WAS UNK WHERE SHOCKING WAS TAKING PLACE EXACTLY. PT HAD A SEIZURE DISORDER AND HAD LOST CONSCIOUSNESS SOMETIME DURING HER VISIT IN THE EMERGENCY ROOM. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE DEVICE WAS INTERROGATED AND THE STIMULATION WAS ON, PROGRAM 2 WAS ACTIVE AND AT 0.4 V. TURNED OFF THE STIMULATION AND THE PT FELT MUCH BETTER PER REPORTER. ADDITIONAL INFO 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 | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3093, LOT# V519456| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD112398N| IMPLANTED:| IMPLANTED: |