MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-21 for ENTERRA 3116 manufactured by Medtronic Puerto Rico Operations Co..
[176831823]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176831824]
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 had a gradual loss of therapy. Their nausea was getting worse for about a year, but recently it had gotten worse. The patient was referred to their hcp to determine if further stimulation adjustment was necessary, but the hcp didn? T want to change any settings. The patient was also getting a shocking sensation. This was initially near the neurostimulator, but later it was within three inches of the neurostimulator. The shocking sensation came gradually from the top of the stomach and then to the bottom of the stomach. The patient noted it was severe contraction. The sensation was not as apparent on the day of the report. It was noted that there were no identifiable issues with impedance that would have caused the shocking sensation. The impedance result on the day of the report showed: 0c at 4,000 ohms, 1c at 4,000 [ohms], 2c at 499 [ohms], 3c at 446 [ohms], 0-1 at 4,000 [ohms], and 2-3 at 499 [ohms]. It was noted that the battery was okay based on the system check and the impedance was appropriate for the therapy. The patient was going to follow-up with the hcp. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[184386112]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184386113]
Additional information received from a healthcare professional (hcp). It was reported that the patient was still having an on/off intermittent shocking sensation. The patient recently went to the hcp to check the device and it was working normally. The patient told the hcp that the sensation was like a vibrating sensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-01473 |
| MDR Report Key | 9612612 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-21 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2014-07-08 |
| Date Added to Maude | 2020-01-21 |
| 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 | 2020-01-21 |
| Model Number | 3116 |
| Catalog Number | 3116 |
| Device Expiration Date | 2015-12-28 |
| 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 | 2020-01-21 |