MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-11 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Lifesciences.
[97382152]
A large impedance change was encountered and is most likely the cause of the error codes that were captured. This large impedance change can result in error codes being generated in a system that is functioning within specifications. Possible causes for this include variations in the interface between the nerve and electrodes, tension being placed on the leads during the impedance check, or inadequate connection between the leads and the rechargeable neuroregulator. No evidence for the specific cause of the high impedance change that was encountered could be positively identified for this event.
Patient Sequence No: 1, Text Type: N, H10
[97382153]
This patient underwent implantation of the maestro rechargeable system on (b)(6) 2017. High impedance readings were received after connection of the rechargeable neuroregulator and application of medical adhesive. Two error codes were then received: code 10 (therapy diagnostic failure) and code 30 (safety check failed). The rechargeable neuroregulator (rnr) was removed during this same procedure and replaced with another rnr without incident. Impedance measurements following replacement of the rnr were within normal range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00002 |
| MDR Report Key | 7185079 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-12-14 |
| Date Mfgr Received | 2017-12-14 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2018-01-11 |
| 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 |
| 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 | 6517892671 |
| Manufacturer G1 | ENTEROMEDICS, INC. |
| 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 | 2018-01-11 |
| Returned To Mfg | 2017-12-18 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Lot Number | 093G13817 |
| Device Expiration Date | 2019-05-07 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-01-11 |