MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-29 for ENTERRA 3116 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[176979002]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176979003]
Information was received from a healthcare professional via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor. It was reported that the patient started feeling an unusual sensation in her right upper quadrant. The healthcare professional checked the patient's pacemaker impedance and it was normal. An x-ray was conducted and the leads appeared to be in the same position. However, when the healthcare professional turned off the pacemaker and the sensation went away. It was a muscle contraction every 40 seconds which lasted 5 seconds or so. The healthcare professional plans to reduce the voltage to see if that might make a difference but feels like the patient is already on a low setting. The patient just had a large hernia repair with mesh. No further patient complications are anticipated or expected as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188943798]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188943799]
Additional information was received from a hcp. It was reported that the hcp had no update as of (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-02100 |
| MDR Report Key | 9642767 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2012-10-11 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| Model Number | 3116 |
| Catalog Number | 3116 |
| Device Expiration Date | 2014-03-28 |
| 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. Required No Informationntervention | 2020-01-29 |