MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-19 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Enteromedics, Inc..
[73253391]
Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[73253392]
This patient underwent implantation of the maestro rechargeable system on (b)(6) 2015. An unanticipated shutdown event of the rechargeable neuroregulator (rnr) was reported on (b)(6) 2017. Multiple attempts to reset the real time clock, clear the unintended shutdown error code, and reconnect the battery in the rnr were unsuccessful. Therapy delivery could not be re-established.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00011 |
| MDR Report Key | 6504798 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2014-10-24 |
| Date Added to Maude | 2017-04-19 |
| 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 | DR. KATHERINE TWEDEN |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6516343209 |
| Manufacturer G1 | ENTEROMEDICS, INC. |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAESTRO RECHARGEABLE SYSTEM |
| Generic Name | RECHARGEABLE NEUROREGULATOR |
| Product Code | PIM |
| Date Received | 2017-04-19 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Lot Number | 093G29714 |
| Device Expiration Date | 2016-06-10 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTEROMEDICS, INC. |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-19 |