MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-07 for SYMMIX 3982 NA manufactured by Medtronic Inc..
[66065]
Pt began complaining of sudden onset of severe pain in her thoracic area, adjacent to the site of her laminectomy. Pt felt severe pain when the physician merely stroked the skin in the area. Physician likened the pain to that associated with shingles. Turning the pulse generator off made no difference in the pt's level of pain, leading the physician to believe that the electrode may be touching one of the thoracic nerves. Physician removed the pt's entire stimulation system, and upon explant, noted that the wires in the lead looked twisted. The system was returned to the mfr for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000032-1997-00186 |
| MDR Report Key | 104336 |
| Report Source | 05 |
| Date Received | 1997-07-07 |
| Date of Report | 1997-05-28 |
| Date of Event | 1997-05-01 |
| Date Mfgr Received | 1997-05-28 |
| Device Manufacturer Date | 1994-05-01 |
| Date Added to Maude | 1997-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMIX |
| Generic Name | IMPLANTABLE STIMULATION LEAD |
| Product Code | LHG |
| Date Received | 1997-07-07 |
| Returned To Mfg | 1997-05-28 |
| Model Number | 3982 |
| Catalog Number | NA |
| Lot Number | L33534 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 102651 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | SYMMIX |
| Baseline Generic Name | SURGICAL EPIDURAL LEAD |
| Baseline Model No | 3982 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | STIM SYMMIX LEAD |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K913934 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-07-07 |