MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-26 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..
[183129912]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183129913]
Information was received from a patient with an implantable neurostimulator (ins). It was reported that the patient could feel the device shocking them and this had been going on for a few months. They have been seeing the doctor. They had the device shut off for a month and did not get shocked during that time. They turned it back on a week ago and was getting shocked again. They did not have any falls or accidents they stated they had a gastrointestinal disorder and had gained weight and did not know if it stretched the wires. The patient sated their doctor had no idea why they were getting shocked. They checked the interference level but did not know how to check if it was in place. No further patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-04068 |
| MDR Report Key | 9754050 |
| Report Source | CONSUMER |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2020-02-26 |
| 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 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERRA |
| Generic Name | INTESTINAL STIMULATOR |
| Product Code | LNQ |
| Date Received | 2020-02-26 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2018-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |