MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-13 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..
[175022874]
Date of event is an approximation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175022875]
Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation. It was reported that the device was removed three weeks prior to the report as it was running too high and? Essentially electrocuting them?. They stated it was not working and they didn? T know why. The device only lasted two years and it malfunctioned. It was also noted that the patient had to go to the emergency room (er) 5-6 weeks prior to the device removal to have the device turned off. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-00912 |
| MDR Report Key | 9581973 |
| Report Source | CONSUMER |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2018-12-28 |
| 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 | 1. Required No Informationntervention | 2020-01-13 |