MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-08-19 for SYMMIX 3982 NA manufactured by Medtronic, Inc..
[67107]
Reported as "pt alleges said spinal cord stimulation system failed to function as intended and had to be removed. Pt alleges she sustained personal injuries, pain and suffering. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-1997-00221 |
| MDR Report Key | 115132 |
| Report Source | 00 |
| Date Received | 1997-08-19 |
| Date of Report | 1997-02-03 |
| Date Mfgr Received | 1997-02-03 |
| Date Added to Maude | 1997-08-26 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 1997-08-19 |
| Returned To Mfg | 1997-02-03 |
| Model Number | 3982 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | Y |
| Device Sequence No | 1 |
| Device Event Key | 113004 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 800 53RD AVE., N.E. 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. Other | 1997-08-19 |