MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-07 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Lifesciences.
[144266484]
The patient visited the clinic on (b)(6) 2019 complaining of a flashing light on the mobile charger with an error code 25 displayed. The clinic reached out to reshape lifesciences field clinical specialist to report the issue and the field clinical specialist asked to have the patient brought back in for further investigation. On (b)(6) 2019, the patient was seen by the clinic. The device lead impedance on the anterior tip to posterior tip was 1583 ohms. With an impedance above 1500 ohms, therapy will not be delivered. The clinic suggested the patient have a complete removal of the device. The removal of the device is scheduled for (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2019-00001 |
| MDR Report Key | 8586248 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-05-07 |
| 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 | 2500 PATTON ROAD |
| Manufacturer City | SAINT PAUL CA 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6517892671 |
| 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 | 2019-05-07 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE LIFESCIENCES |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-07 |