MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-23 for MAESTRO RECHARGABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc.
[83747340]
This patient experienced a flashing red light on their device approximately (b)(6) 2017. On (b)(6) 2017, the site reported that they could not restart therapy. The clinician programmer indicated error code 25 (too many therapy retries). Impedance testing indicated high posterior tip to ring and anterior tip to posterior tip impedance measurements. Device remains implanted, but therapy is not being delivered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00019 |
| MDR Report Key | 6814574 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-23 |
| Date of Report | 2018-05-21 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2014-12-04 |
| Date Added to Maude | 2017-08-23 |
| 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 |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAESTRO RECHARGABLE SYSTEM |
| Generic Name | POSTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2017-08-23 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | CR-01897 |
| Device Expiration Date | 2017-12-01 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2017-08-23 |