MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-05 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Life Sciences.
[119828544]
On (b)(6) 2018, patient (b)(6) at the university (b)(6) was unable to charge the device and had a flashing red light on the mc. The reshape lifesciences field specialist connected her to the cp and alarm codes #4 and #25 were observed. These alarms were cleared and the flashing red light disappeared. The cp continued to ask to start a charge as the rnr battery was extremely low. After about 15 minutes of charging using the patients mc, therapy was able to be adjusted and a live test performed. On-demand impedance measurement was performed and the results were as follows: 934, 1033, 677. Before the patient left, another on-demand impedance test was performed, the readings were as follows: 821, 1062, 0. A red flashing light was observed on the mc. The patient was hooked up to the cp to clear the red light and was sent home. On (b)(6) 2018, the patient indicated they received another flashing red light.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00009 |
| MDR Report Key | 7848028 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-06 |
| Date Added to Maude | 2018-09-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RANDY HOYT |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6516343025 |
| Manufacturer G1 | RESHAPE LIFESCIENCES |
| 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 | 2018-09-05 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE LIFE SCIENCES |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-05 |