MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-21 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..
[183754447]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183754448]
Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins). It was reported that the patient was at 7. 5 ma and had one adjustment in (b)(6) 2019. The hcp was able to palpate the ins but could not interrogate the device after several attempts. They were using the correct device and software card. A manufacturer representative (rep) was paged to assist the hcp. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[184373437]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184373438]
Additional information was received and the health care professional stated that the inability to palpate the ins was resolved and the cause was unknown. No further complications noted or anticipated
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-03880 |
| MDR Report Key | 9742079 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-17 |
| Date Added to Maude | 2020-02-21 |
| 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 | 2020-02-21 |
| Model Number | 37800 |
| Catalog Number | 37800 |
| 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 | 2020-02-21 |