INTERSTIM
Report
- Report Number
- 2182207-2008-06874
- Event Type
- Injury
- Date Received
- October 24, 2008
- Report Date
- September 30, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
RESULTS - PATIENT PROGRAMMER.
JOURNAL REFERENCE: GSTALTNER K, ROSE H, HUFGARD J, MARK R, SCHREI K. SACRAL NERVE STIMULATION AS AN OPTION FOR THE TREATMENT OF FAECAL INCONTINENCE IN PATIENTS SUFFERING FROM CAUDA EQUINE SYNDROME. SPINAL CORD. 2008;46(9): 644-647. CAUDA EQUINA SYNDROME (CES) IS A LESION OF THE PERIPHERAL NERVOUS SYSTEM WHICH CAN OCCUR IN PATIENTS SUFFERING FROM CES AS A RESULT OF A TRAUMA IN THE REGION OF THE LUMBAR SPINE. CLINICALLY, IT INVOLVES FLACCID PARESIS OF THE STRIATED MUSCLES DISTAL TO THE LESION, THE PELVIC FLOOR AND THE BLADDER. LOSS OF FUNCTION AND TONUS OF THE EXTERNAL SPHINCTER AS WELL AS PARAESTHESIA CAN ALSO BE SEEN. IT WAS OUR AIM TO IMPROVE SPHINCTER FUNCTION AND ANAL SENSITIVITY TO ACHIEVE VOLUNTARY RECTAL DEFAECATION. IMPLANT OF THE PERMANENT SNS SYSTEM WAS CARRIED OUT IN SOME PATIENTS. IN ALL CASES, ONE TINED LEAD ELECTRODE WAS IMPLANTED. THE POST-OP PROCESSES TOOK PLACE WITHOUT ANY COMPLICATIONS AND ALL PATIENTS WERE FOLLOWED UP FOR A MIN. OF 1 YR. REPORTABLE EVENT: ONE PT DESCRIBED ACUTE FAECAL INCONTINENCE 14 MONTHS AFTER THE PROCEDURE. THE PT HAD INADVERTENTLY DEACTIVATED THE NEUROSTIMULATOR BY THE USE OF HER OWN REMOTE CONTROL. AS SOON AS WE REACTIVATED, THE SYSTEM WAS CONTINENT AGAIN. SEE MGR REPORT # 2182207-2008-06873.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC NEUROMODULATION | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD: MODEL 3093 N=1| PROGRAMMER: MODEL 8840 N=1| PATIENT PROGRAMMER: MODEL 3031A N=1 |