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.
[106955237]
On (b)(6) 2016, during initial phase of surgery prior to opening the device packaging, a reshape field clinical specialist was attempting to check the rnr battery level and status using the site mc and the site's physician coil. A red flashing status led was observed immediately. The field clinical specialist opened a cp session to interrogate rnr and read an alarm message relating to magnet swipe. The field clinical specialist attempted to follow prompts and clear alarm, however, the cp failed to clear alarm and presented additional error message regarding the reed switch closed and inability to correct issue, instructing user to contact emi. A new rnr was used, the cp was restarted prior to interrogating the new rnr per recommended cp shutdown method and the case was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00004 |
| MDR Report Key | 7466424 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2016-06-14 |
| Date Mfgr Received | 2016-06-14 |
| 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 CA 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 | RECHARGEABLE NEUROREGULATOR |
| Product Code | PIM |
| Date Received | 2018-04-26 |
| Returned To Mfg | 2016-06-15 |
| 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 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 |