MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-20 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..
[183766002]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183766003]
Information was received from a patient with an implantable neurostimulator (ins) for the treatment of other. It was reported that t he patient had been having problems with the device shocking them. They stated it had been on and off for over a year. They turned the device off and the shocks stopped but their symptoms returned very quickly. They stated the previous night they raised their right arm and got shocked. They were sitting on the couch and every few minutes the device would shock them and this went on for a couple hours. The patient stated they had not had any falls or trauma. They stated they tried setting the device at lower settings. No further patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[184387243]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184387244]
Additional information received. The patient called back indicating she is working with her physician's office to get codes for insurance approval to undergo device replacement due to the shocks she has been experiencing and is in a lot of pain and additionally reported that as of the night before last she started vomiting again. No further complications noted or anticipated
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-03786 |
| MDR Report Key | 9736270 |
| Report Source | CONSUMER |
| Date Received | 2020-02-20 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2020-02-20 |
| 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 | 2020-02-20 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2018-08-28 |
| 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 | 2020-02-20 |