MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for INTERSTIM 97810 manufactured by Rice Creek Mfg.
[188415110]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188415111]
The manufacture representative reported a shocking sensation that was initially resolved by putting a piece of cloth between the skin and the recharger. Charging on bare skin triggers the event. The wound was clean and dry, but not healed yet. There was a suspicion that shocking sensation is related to wound healing process. When the device was replaced the same pocket was used, they didn? T create a smaller pocket. Healthcare provider did not use the suture loop. It was noted that the patient experienced poor recharge coupling. A service code 1707 was given and the ins was currently 10% charged. It was also noted that impedances were measured and were all in range. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000030-2020-00121 |
| MDR Report Key | 9819540 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | RICE CREEK MFG |
| Manufacturer Street | 7000 CENTRAL AVE NE |
| Manufacturer City | FRIDLEY MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERSTIM |
| Generic Name | INTESTINAL STIMULATOR |
| Product Code | LNQ |
| Date Received | 2020-03-11 |
| Model Number | 97810 |
| Catalog Number | 97810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |