MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-18 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..
[183934996]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183934997]
Information was received from a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation. It was reported that the patient was scheduled for surgery on (b)(6) 2019. Additional information on (b)(6) 2020 reported that the surgery was to remove the stimulator. The patient had no relief in their symptoms unless the device was turned all the way up. If it was all the way up, the battery only lasted two months. It was also noted that the patient had pain and muscle spasms and wanted the device removed. They hadn? T used the stimulator in over a year and their symptoms were being managed with medications. A collective decision was made between the surgeon, hcp, and patient to remove the device for patient comfort. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[187335905]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187335906]
Additional information was received and it was stated that the device is still in use and the elective removal was cancel due to the coronavirus pandemic. No further complications noted or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-05623 |
| MDR Report Key | 9848877 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2017-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-18 |