MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for 7424 manufactured by Medtronics.
[17439328]
Spinal epidural stimulator implanted on april 27, 1993, for chronic radicular leg pain. The stimulator at this time is no longer functioning well, and intermittently shocks her. Re-admitted on june 29, 1993, for revision of the spinal epidural stimulator. Device labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7757 |
| MDR Report Key | 7757 |
| Date Received | 1994-02-04 |
| Date of Report | 1993-07-09 |
| Date of Event | 1993-06-29 |
| Date Facility Aware | 1993-06-29 |
| Report Date | 1993-07-09 |
| Date Reported to Mfgr | 1993-06-29 |
| Date Added to Maude | 1994-05-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SPINAL EPIDURAL STIMULATOR |
| Product Code | GZD |
| Date Received | 1994-02-04 |
| Model Number | 7424 |
| ID Number | QT2 110 319H |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7436 |
| Manufacturer | MEDTRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-02-04 |