MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-15 for INTERSTIM 3889-28 manufactured by Medtronic, Inc..
[94944931]
Patient Sequence No: 1, Text Type: N, H10
[94944932]
She had anterior and posterior prolift meshes that we have removed. She has stool incontinence with urgency incontinence. After the interstim insertion, she greatly improved her symptoms. The urgency and frequency of urine and stool were practically gone. Unfortunately, she developed progressively significant pain over the device. The device was turned off and the pain disappeared. A diagnosis of electrical leak was made and the device had to be removed. In the future, if desired, we will insert another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7120554 |
| MDR Report Key | 7120554 |
| Date Received | 2017-12-15 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-08-21 |
| Report Date | 2017-12-11 |
| Date Reported to FDA | 2017-12-11 |
| Date Reported to Mfgr | 2017-12-11 |
| Date Added to Maude | 2017-12-15 |
| 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 | 3 |
| 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 | INTERSTIM |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE |
| Product Code | KPI |
| Date Received | 2017-12-15 |
| Model Number | 3889-28 |
| Catalog Number | 3889-28 |
| Lot Number | VA1BVE6 |
| ID Number | MP6860 LEAD, 4 ELECTRODE 28CM |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-15 |