INTERSTIM
Report
- Report Number
- 3004209178-2012-01583
- Event Type
- Injury
- Date Received
- March 15, 2012
- Report Date
- February 19, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
LEAD: MODEL 3093-33, LOT# V021284, IMPLANTED: 2007 (B)(6), EXPLANTED: NA; EXTENSION: MODEL 3095-10, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: NA; PROGRAMMER: MODEL 3031A, SERIAL# (B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE NEUROSTIMULATOR SITE AND A LACK OF THERAPEUTIC EFFECT, STARTING ON (B)(6) 2012. THE PATIENT WAS AT THE HOSPITAL FOR AN UNRELATED ISSUE, AND A URINARY TRACT INFECTION WAS RULED OUT AS A CAUSE FOR HER PAIN AND URINARY FREQUENCY. THE PATIENT HAD BEEN USING A HEATING PAD AT THE SITE OF THE PAIN, WHICH HAD HELPED SOME. THE PATIENT WAS ALSO UNABLE TO ADJUST STIMULATION. HER PATIENT PROGRAMMER WAS FUNCTIONAL AGAIN ONCE THE BATTERIES WERE REPLACED, AND IT WAS DISCOVERED THAT THE INS WAS TURNED OFF. THE NEUROSTIMULATOR WAS TURNED BACK ON AND THE PATIENT ADJUSTED HER SETTINGS UNTIL SHE COULD FEEL COMFORTABLE STIMULATION. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH HER HCP SCHEDULED FOR (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS A NON-FUNCTIONING NEUROSTIMULATOR (INS). THE INS WAS REPLACED AND IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |