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 Medical.
[107196174]
The device was implanted on (b)(6) 2016. The rnr had a flashing red light during implantation, half-way through patient registration with the cp. The rnr was replaced and the case was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00006 |
| MDR Report Key | 7466433 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-10-26 |
| Device Manufacturer Date | 2015-09-02 |
| 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 | 2016-11-08 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Lot Number | 093G13315 |
| Device Expiration Date | 2017-03-02 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE MEDICAL |
| 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 |