MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2017-05-24 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..
[75923995]
Patient Sequence No: 1, Text Type: N, H10
[75923996]
A subject participating in the (b)(6) trial (subject id (b)(6)) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011. This subject has had a history of multiple low impedance events related to the implanted posterior lead, resulting in a need to restart therapy. Reported low impedance events for this subject occurred on (b)(6) 2014, (b)(6) 2015, (b)(6) 2016, and a final report of continued impedance issues on (b)(6) 2016. On (b)(6) 2016, it was also reported that this subject is unreliable with charging and attending clinic visits. On april 27, 2017, enteromedics was informed that this subject has decided to have the device explanted. The device was subsequently explanted without incident on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00013 |
| MDR Report Key | 6589485 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-05-24 |
| Date of Report | 2017-08-23 |
| Date of Event | 2016-05-03 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2011-06-08 |
| Date Added to Maude | 2017-05-24 |
| 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 |
| Reporter Occupation | PHYSICAL THERAPIST |
| 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 | 2017-05-24 |
| Returned To Mfg | 2017-08-08 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | C4-07865 |
| Device Expiration Date | 2014-06-01 |
| 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 | 2017-05-24 |