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 2016-12-01 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Enteromedics, Inc..
[61243992]
Device remains implanted; not returned.
Patient Sequence No: 1, Text Type: N, H10
[61243993]
(b)(6) subject participating in the (b)(6) clinical trial was implanted with the maestro rechargeable system on (b)(6) 2011. During a clinic visit on (b)(6) 2016, it was determined that a short circuit of the anterior lead had been experienced on (b)(6) 2016 and an anterior lead open circuit was experienced on (b)(6) 2016. This subject first reported a flashing red light on the mobile charger during the clinic visit on (b)(6) 2016. During this visit, alarms were noted for low rnr battery, the anterior tip to ring short circuit, and the anterior lead open circuit. Therapy was re-started at this visit, and alarms were cleared. Red light was reported by subject to have returned on (b)(6) 2016. During an additional clinic visit on (b)(6) 2016, alarm code 3 (impedance high) was encountered. Diagnostic evaluation reported by the site included another anterior lead tip to ring open circuit on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[65938120]
(b)(6) subject participating in (b)(6) was implanted with the maestro rechargeable system on (b)(6) 2011. During a clinic visit on (b)(6) 2016, it was determined that a short circuit of the anterior lead had been experienced on (b)(6) 2016 and an anterior lead open circuit was experienced on (b)(6) 2016. This subject first reported a flashing red light on the mobile charger during the clinic visit on (b)(6) 2016. During this visit, alarms were noted for low rnr battery, the anterior tip to ring short circuit, and the anterior lead open circuit. Therapy was re-started at this visit, and alarms were cleared. Red light was reported by subject to have returned on (b)(6) 2016. During an additional clinic visit on (b)(6) 2016, alarm code 3 (impedance high) was encountered. Diagnostic evaluation reported by the site included another anterior lead tip to ring open circuit on (b)(6) 2016. Update: device was explanted on (b)(6) 2016. Extensive adhesions were noted during the explant. The entire maestro rechargeable system was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2016-00012 |
| MDR Report Key | 6137994 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2016-12-01 |
| Date of Report | 2017-01-18 |
| Date of Event | 2016-11-02 |
| Date Mfgr Received | 2016-12-22 |
| Device Manufacturer Date | 2011-06-06 |
| Date Added to Maude | 2016-12-01 |
| 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 | 2016-12-01 |
| Returned To Mfg | 2017-01-04 |
| Model Number | 2200A-47E |
| Catalog Number | 2200A-47E |
| Lot Number | C4-07861 |
| 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. Other; 2. Required No Informationntervention | 2016-12-01 |