FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2595764
·
Received June 1, 2012
Report
- Report Number
- 3004209178-2012-03913
- Event Type
- Injury
- Date Received
- June 1, 2012
- Date of Event
- May 4, 2012
- Report Date
- May 4, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LEAD: MODEL 3889-28, LOT# V802377, IMPLANTED: 2011 (B)(4), EXPLANTED: PROGRAMMER: MODEL 3037, SERIAL# (B)(4). (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. THE INS POCKET WAS REVISED DUE TO PAIN, AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION.
Description of Event or Problem · 1
THE PATIENT UNDERWENT A REVISION SURGERY ABOUT AN HOUR AGO DUE TO THE INS MOVING AROUND AND IT CAUSED HIM PAIN. HE WAS NOT ABLE TO ADJUST STIMULATION. THE "CALL YOU DOCTOR" ICON DISPLAYED. A POWER ON RESET OCCURRED (POR). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |