MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-08 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..
[74630837]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[74630838]
The patient? S friend/family member reported that the patient was currently in the hospital and believes the hospital visits were related to the device. They were looking for a healthcare provider to assist with the patient? S symptoms and device. Since the patient? S device was implanted the patient had been in the hospital once a month and was? Dwindling.? The patient? S friend/family member did not know what the issue was with the device. Since the patient was implanted they hurt all of the time, was throwing up terribly and all of the time gets rushed to the hospital. The patient? S friend/family member was calling the ambulance every month. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[83360070]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[83360151]
Additional information from the patient reported their current weight was (b)(6) and if they gain (b)(6), then they get sick and lose the weight within a week. They stated that the device is "recharged" every 3 months, however they were told they can't increase any higher. The current settings were 10 and 5. 2. The patient was scheduled to see a new hcp on (b)(6) 2017 to review the situation as they were going to the hospital too often. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[102358928]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2017-09838 |
| MDR Report Key | 6551493 |
| Report Source | CONSUMER |
| Date Received | 2017-05-08 |
| Date of Report | 2017-07-02 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2017-06-27 |
| Device Manufacturer Date | 2015-05-05 |
| Date Added to Maude | 2017-05-08 |
| 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 | 2017-05-08 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2016-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| 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 |
| Brand Name | ENTERRA |
| Generic Name | INTESTINAL STIMULATOR |
| Product Code | LQN |
| Date Received | 2017-05-08 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2016-10-28 |
| 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 | 1. Hospitalization | 2017-05-08 |