MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for MEDTRONIC INTERSTIM ICON manufactured by Medtronic Neuromodulation.
[91872202]
Patient states that she began experiencing a shocking feeling on the left foot and also had two of her toes curling involuntarily. She then states that in (b)(6), she had to have surgery in order to replace the battery for the interstim due to an electrical short. The battery was said to last 3-5 years yet, failed to last even 1 year. She states that recently she had surgery on (b)(6), to treat a bone spur in her left foot as a result of the interstim.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073208 |
| MDR Report Key | 7013660 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-08 |
| Date of Event | 2016-01-04 |
| Date Added to Maude | 2017-11-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | MEDTRONIC INTERSTIM ICON |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTABLE |
| Product Code | KPI |
| Date Received | 2017-11-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2017-11-09 |