MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-11 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Life Sciences.
[123513163]
On (b)(6) 2018, patient 835-bam at skyridge experienced a red flashing light on the mc when connecting with the rnr at a post-op visit. The reshape field specialist tried several times to clear the flashing red lights when connected to the cp, however, the cp "locked up. " the field specialist then hooked up another rnr (implant kit) to the cp, the red light disappeared and a green flashing light appeared on the mc signaling the patient was receiving therapy. The rnr logs were unable to upload due to the lock out on the cp, however, debug and data files were sent for investigation. On (b)(6) 2018, the field specialist met with the patient to attempt to connect the device to the cp again to clear the alarms. After several attempts, the cp was remained locked. The field specialist expressed to the implanting physician if they are unable to resolve this issue, revision surgery may be necessary. On (b)(6) 2018, the implanting physician performed revision surgery, removed the rnr and replaced with a new rnr. The device performed as expected and patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00010 |
| MDR Report Key | 7958255 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-08-03 |
| Date Added to Maude | 2018-10-11 |
| 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 | BIOMEDICAL ENGINEER |
| 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 LIFE SCIENCES |
| 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 | 2018-10-11 |
| Returned To Mfg | 2018-08-06 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-11 |