MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-27 for ENTERRA 3116 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[183142494]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183142495]
Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.?? It was reported gastric stimulation.?? It was reported that patient has a funny feeling it is not working again/ therapy not working anymore because last week or so he has been so bloated and he had diarrhea again as his gastroparesis has gotten worse. Patient further stated that they noticed the symptoms since after the colonoscopy and endoscopy a couple weeks ago and they think the battery might be dead. Patient wants the mdt rep to come check his battery level at his doctor appointment in april. No further complications were noted or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[187336158]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187336159]
Additional information received from a consumer (con). It was reported that the patient didn't know if the device died, but they knew they were sick and had been for quite some time. They repeated they had a colonoscopy and an endoscopy and their doctor said they were all clear. The patient stated that no steps were taken to resolve the device being dead as they did not even know if it was dead. They stated they never had a relief of symptoms and it caused nausea, diarrhea, and vomiting. They also stated that they even passed out in their doctor? S office. The patient had anxiety from the pain that they were experiencing and they had been constipated at times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-04201 |
| MDR Report Key | 9764136 |
| Report Source | CONSUMER |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2009-11-10 |
| Date Added to Maude | 2020-02-27 |
| 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 MED REL MEDTRONIC PUERTO RICO |
| 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 | 2020-02-27 |
| Model Number | 3116 |
| Catalog Number | 3116 |
| Device Expiration Date | 2011-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| 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. Other | 2020-02-27 |