MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Lifesciences.
[100890751]
The patient reported that she feels a zap in the right side of her abdomen which results in unbearable pain. She experiences it at least once or twice a week and the episodes last for 20-30 mins. She believes that it is related to the implant and let the battery die completely. She hasn't received therapy since (b)(6) and hasn't had one of those episodes since. The physician feels that it might not be related to the device but has something to do with her gallbladder. The patient agreed to give try again for 2 weeks so the device was restarted. The device was recharged, therapy was adjusted to 10 hours per day, and the patient was trained how to turn the device off in case the pain returns. The patient returned approximately 2 weeks later with the same issue. She had one of those episodes on the same day we turned her device back on. She feels that the devices makes her extremely gassy and bloated also. The device was turned off. The patient wants to wait and watch for a month to see if there is any improvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00003 |
| MDR Report Key | 7293913 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-06-07 |
| Date of Event | 2017-10-15 |
| Date Mfgr Received | 2018-01-26 |
| Device Manufacturer Date | 2016-08-11 |
| Date Added to Maude | 2018-02-23 |
| 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 | 0 |
| Brand Name | MAESTRO RECHARGEABLE SYSTEM |
| Generic Name | RECHARGABLE NEUROREGULATOR |
| Product Code | PIM |
| Date Received | 2018-02-23 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Lot Number | NR-000418 |
| Device Expiration Date | 2018-11-23 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-02-23 |