MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-09-30 for * 3127 NA manufactured by Medtronic, Inc..
[113671]
Report from attorney states "pt volunteered to participate in a demonstration of a neuromuscular stimulator performed by a physical therapist. The stimulator was attached to the pt's right arm with two electrodes. The stimulator was turned on with no apparent effect to the pt. The stimulator was allegedly pressed on the electrodes whereupon the pt received a shock to her right arm"
Patient Sequence No: 1, Text Type: D, B5
[15891568]
"ni" changed to "unk" as device has not been received by mfr for analysis. Due to pending litigation, it is unlikely that device will be returned to mfr for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182207-1997-00250 |
| MDR Report Key | 124239 |
| Report Source | 00 |
| Date Received | 1997-09-30 |
| Date of Report | 1997-08-26 |
| Date Mfgr Received | 1997-08-26 |
| Date Added to Maude | 1997-10-06 |
| 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 | * |
| Generic Name | * |
| Product Code | GZI |
| Date Received | 1997-09-30 |
| Model Number | 3127 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 121643 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | * |
| Baseline Generic Name | * |
| Baseline Model No | 3127 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-09-30 |