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 2020-03-19 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..
[184201961]
Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2020, product type: lead, product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 21-jan-2013, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 21-jan-2013, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184201962]
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation. It was reported that there was a? Check ins clock? On the clinician programmer. The patient was in severe pain and they were doing well 7-10 days prior to the report. It was noted that it looked like a possible lead sticking up on the esophagogastroduodenoscopy (egd), but it was submucosal. Additional information was received from the hcp via the rep. It was reviewed that the ins and clinician programmer were off by one hour. Additional information was received from the manufacturer representative (rep). The patient? S identifying information was provided. It was reported that they were not sure what the cause of the? Check ins clock? Message was even after confirming with the healthcare professional (hcp). The rep instructed the hcp how to correct the time in the ins but they did not have confirmation that this was done. An egd was performed and there was evidence of lead migration in the stomach. They did not know what caused it. The patient was referred to a different hcp who replaced both leads and ins on (b)6) 2020. The patient was doing much better. No further patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-05745 |
| MDR Report Key | 9857403 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2017-06-30 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2018-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2020-03-19 |