MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-17 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Lifesciences.
[117616497]
This complaint was not originally reported. After engineering reviewed the cp log data, it was determined the root cause of the customer's experience was likely a damaged anterior lead.
Patient Sequence No: 1, Text Type: N, H10
[117616498]
Patient subject (b)(6) at (b)(6) who was originally an empower patient and has converted to the rechargeable system. The patient was experiencing a flashing red light on their mc. Reshape's field specialist met the patient on (b)(4) 2018. When connected to the cp, error codes #25 and #4 were displayed and cleared. The on demand impedances were as follows: 954, 1198, 795, and 804, 735, 6548. The therapy was restarted. A live test was performed and the patient was sent home receiving therapy. On may 18, 2018, reshape received additional information when the field specialist visited the site. After reviewing the logs, the patient received therapy for 13 days before a low impedance alarm was triggered. The cp cleared the alarms and on demand impedance measurements were performed as followed: 960, 1211, 781 and 967, 1241, 781. Another live test was performed and the patient was sent home receiving therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00008 |
| MDR Report Key | 7795492 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-24 |
| Date Added to Maude | 2018-08-17 |
| 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 | 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 | 2018-08-17 |
| 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 LIFESCIENCES |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-17 |