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 2017-02-09 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Enteromedics, Inc..
[67233582]
Subject participating in the (b)(6). This subject was implanted with the maestro rechargeable system on (b)(6) 2011. During a clinic visit on (b)(6) 2016, error codes were received for low impedance of the anterior lead and too many therapy retries. Alarms were cleared and therapy resumed. Therapy was again interrupted from (b)(6) 2016. During a clinic visit on (b)(6) 2016, the same error codes as occured on (b)(6) 2016 were cleared and therapy was resumed. On (b)(6) 2017 an anterior tip to anterior ring short was experienced again. The device was explanted on (b)(6) 2017. Extreme scarring and adhesions were noted at explant. However, the entire device was able to be explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00004 |
| MDR Report Key | 6316569 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2017-02-09 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-01-12 |
| Date Mfgr Received | 2017-02-06 |
| Device Manufacturer Date | 2011-06-24 |
| Date Added to Maude | 2017-02-09 |
| 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 | 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 | ANTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2017-02-09 |
| Returned To Mfg | 2017-02-14 |
| Model Number | 2200A-47E |
| Catalog Number | 2200A-47E |
| Lot Number | C4-07862 |
| 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 | 2017-02-09 |