MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2017-05-24 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..
[75967249]
Explanted device not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[75967250]
This subject is a participant in the (b)(6) clinical trial. This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014. Impedance issues were reported related to the implanted anterior lead (reference mdr3005025697-2017-00001 for information on that component). During a revision procedure to replace the anterior lead, it was discovered that the anterior lead and posterior lead were twisted around each other in the pocket of the rechargeable neuroregulator. As a result, the posterior lead was also replaced. The revision procedure was successfully completed without adverse impact to the subject. Explanted device components have not yet been received by enteromedics. Reference mdr3005025697-2017-00001 for report related to the anterior lead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00014 |
| MDR Report Key | 6589490 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2017-05-24 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-04-24 |
| Date Mfgr Received | 2017-06-01 |
| 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 |
| 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 | 2017-06-01 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | CR-01826 |
| Device Expiration Date | 2017-01-01 |
| 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 |