MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-05 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..
[56481576]
Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[56481577]
(b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011. This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013. On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit. The associated alerts were cleared during the visit, but recurred within 24 hours. As a result, this subject is not receiving therapy from the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2016-00009 |
| MDR Report Key | 6000063 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-05 |
| Date of Report | 2017-12-01 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2016-10-05 |
| 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 | POSTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2016-10-05 |
| Returned To Mfg | 2017-11-06 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | 11716-555 |
| Device Expiration Date | 2014-09-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-10-05 |