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 2017-01-18 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..
[65218679]
A subject participating in the recharge clinical trial (subject id (b)(6) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011. Subject presented with red light (b)(6) 2015. Interrogation with clinician programmer indicated posterior tip to ring short since (b)(6) 2015 with display of error message. Therapy was restarted by site. Same issue occurred (b)(6) 2015 and again on (b)(6) 2015 with therapy restarted after each event. Maestro rechargeable system was explanted on (b)(6) 2015. Subject experienced seroma following explant which resolved without surgical or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00003 |
| MDR Report Key | 6262399 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-01-18 |
| Date of Report | 2017-01-18 |
| Date of Event | 2015-08-12 |
| Date Mfgr Received | 2015-08-12 |
| Device Manufacturer Date | 2011-07-11 |
| Date Added to Maude | 2017-01-18 |
| 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 | DR KATHERINE TWEDEN |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6516343209 |
| 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 | 2017-01-18 |
| Returned To Mfg | 2015-08-12 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | C4-08020 |
| Device Expiration Date | 2014-07-01 |
| 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 | 2017-01-18 |