MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-01 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Enteromedics, Inc..
[68752205]
A former subject in the (b)(6) clinical trial (ide (b)(4); subject id (b)(6)) was originally converted to a maestro rechargeable system on (b)(6) 2015. The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016 (refer to mdr 3005025697-2017-00005 through mdr 3005025697-2017-00007 for details on original rechargeable system removal due to excessive manipulation). On (b)(6) 2016, the site reported that alerts for low impedance were experienced at follow-up, noting that the ring electrodes were places quite close together at implant. On (b)(6) 2016, it was reported that low impedance measurements were again experienced. Radiograph review suggested that the ring electrodes were in very close proximity to each other with twisting of the leads near the neuroregulator. The replacement system was explanted on (b)(6) , 2016. Mdr's related to this issues are: mdr 3005025697-2017-00008: model 2002 rechargeable neuroregulator, mdr 3005025697-2017-00009: model 2200a-47e anterior lead, mdr 3005025697-2017-00010: model 2200p-47e posterior lead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00009 |
| MDR Report Key | 6370103 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date of Event | 2016-09-21 |
| Date Mfgr Received | 2016-04-14 |
| Date Added to Maude | 2017-03-01 |
| 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 | 2017-03-01 |
| Returned To Mfg | 2017-02-07 |
| Model Number | 2200A-47E |
| Catalog Number | 2200A-47E |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2017-03-01 |