MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-01-21 for INNOVA PFS 198899 NA manufactured by Empi, Inc..
[19147461]
Contrary to explicit labeling, a incontinence device was used on a pacemaker pt who claimed the pacemaker unit turned off and the pt became unconsious for a period of time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182686-1996-00005 |
| MDR Report Key | 65577 |
| Report Source | 04 |
| Date Received | 1997-01-21 |
| Date of Report | 1996-12-19 |
| Date of Event | 1996-11-17 |
| Date Mfgr Received | 1996-11-21 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 1997-01-31 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVA PFS |
| Generic Name | INCONTINENCE DEVICE |
| Product Code | KPI |
| Date Received | 1997-01-21 |
| Model Number | 198899 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 65671 |
| Manufacturer | EMPI, INC. |
| Manufacturer Address | 599 CARDIGAN ROAD ST PAUL MN 551263965 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-21 |