MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2017-04-19 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Enteromedics, Inc..
[73254448]
Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[73254449]
Subject participating in the (b)(6) reported a flashing red light on (b)(6) 2017. During a clinic visit on (b)(6) 2017, multiple error code messages were reported including 12 (pulse current below minimum threshold), 3 (high impedence for 60 minutes), and 25 (too many therapy retries). Anterior lead tip to ring and anterior tip to posterior tip impedance readings of >65 kohms were also reported, indicating an open circuit. Therapy could not be re-started.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00012 |
| MDR Report Key | 6504794 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2017-04-19 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-09-01 |
| Device Manufacturer Date | 2014-01-24 |
| Date Added to Maude | 2017-04-19 |
| 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 | ANTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2017-04-19 |
| Returned To Mfg | 2017-09-11 |
| Model Number | 2200A-47E |
| Catalog Number | 2200A-47E |
| Lot Number | CR-01825 |
| 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 | 2017-04-19 |