MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-01 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Enteromedics, Inc..
[61228569]
This patient was implanted with the maestro rechargeable system on (b)(6) 2016. On november 3, 2016, it was reported that the patient has been experiencing pain at the site of the implanted rechargeable neuroregulator (rnr) and requested device explant. The maestro rechargeable system was reported to have been subsequently explanted without incident on (b)(6) 2016. No infection was reported. Pain at the rnr site is a known possible effect of device implantation included in device labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2016-00013 |
| MDR Report Key | 6137998 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-01 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-11-03 |
| Date Mfgr Received | 2016-11-03 |
| Device Manufacturer Date | 2015-07-10 |
| Date Added to Maude | 2016-12-01 |
| 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 | MS. LISA PRITCHARD |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6517892681 |
| 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 | 2016-12-01 |
| Returned To Mfg | 2016-11-17 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Lot Number | 093G19115 |
| Device Expiration Date | 2017-02-05 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTEROMEDICS, INC. |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-01 |