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 37800 manufactured by Medtronic Puerto Rico Operations Co..
[176876993]
Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176876994]
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 the patient experienced pain at the site of the battery with a pulsing sensation every five seconds. A clinician programmer was used to turn off the patient? S device and run an impedance check. It was unknown if the issue was resolved. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[184375091]
Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2017. Product type lead, product id 4351-35, serial# (b)(4), implanted: (b)(6) 2017. Product type lead if information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184375092]
Additional information was received from the rep. They reported that the device was turned off by the doctor. The patient was reporting pain after the device was turned off. They were discharged from the hospital with the battery turned off and were instructed to follow up with their managing physician. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-02116 |
| MDR Report Key | 9643436 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2017-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-01-29 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| Device Expiration Date | 2018-08-28 |
| 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 | 2020-01-29 |