MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-16 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Lifesciences.
[114087478]
The physician reported patient (b)(6) had an rnr pocket infection. The physician treated the patient with antibiotics and they responded positive clinically; however, when the physician takes the patient off antibiotics, the infection flares up. Therefore, the patient and the physician decided to explant the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00007 |
| MDR Report Key | 7691289 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-06-15 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-07-16 |
| 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 | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6517892671 |
| Manufacturer G1 | RESHAPE MEDICAL |
| 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 | 2018-07-16 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-07-16 |