MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-29 for ENTERRA 3116 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[176848429]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176848430]
Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation. It was reported that, when the swelling went down close to (b)(6) (2013), they noticed a lump on their rib. Their rib and lungs hurt and they experienced difficulty breathing. They mentioned these concerns to their healthcare professional (hcp), but the issue was not addressed. Around (b)(6) 2013, they noticed that it was becoming even more difficult to breathe. Finally, around (b)(6) 2013, a revision was performed. No device issues or further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-02117 |
| MDR Report Key | 9643509 |
| Report Source | CONSUMER |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2013-01-28 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2012-09-17 |
| 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 | 2014-03-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |