MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-26 for MAESTRO RECHARGABLE SYSTEM 2002 manufactured by Reshape Medcial.
[107196113]
The rnr was implanted on (b)(6) 2016, the dissection and lead placement went well. The leads were connected to the rnr and initial impedance measurements were 688, 883, and 953. Therapy was then activated. Before a live test could be performed, the cp displayed error code #14, regulator hv voltage above max threshold. The error code box was closed and then the cp immediately ended the session. The reshape clinical field specialist attempted to reconnect the rnr three more times and the same error message would appear and then close the session. A new rnr was registered and implanted successfully without any issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00005 |
| MDR Report Key | 7466427 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-08-25 |
| Date Added to Maude | 2018-04-26 |
| 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 | MRS. KRISTIN WIELENGA |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 9492188639 |
| Manufacturer G1 | RESHAPE MEDICAL |
| 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 RECHARGABLE SYSTEM |
| Generic Name | RECHARGABLE NEUROREGULATOR |
| Product Code | PIM |
| Date Received | 2018-04-26 |
| Returned To Mfg | 2016-08-29 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE MEDCIAL |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-26 |