MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-01 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..
[68750175]
A former subject in the empower clinical trial (ide (b)(4); (b)(6)) was converted to a maestro rechargeable system on (b)(6) 2015. At the conversion procedure, the original investigational rf neuroregulator was replaced with the commercial model 2002 rechargeable neuroregulator. The anterior and posterior leads, implanted as part of the empower clinical trial on (b)(6) 2008, were not replaced at the time of the conversion to the rechargeable system. On (b)(6) 2015 the site reported that this patient was experiencing low impedance of the anterior lead with related error codes. Therapy was restarted but then the issue returned. Review of radiograph images suggest that this issue was caused by excessive device manipulation by the patient. The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016. Mdrs related to this issue are: mdr3005025697-2017-00005: model 2002 rechargeable neuroregulator; mdr3005025697-2017-00006: model 2200a-47e anterior lead; mdr3005025697-2017-00007: model 2200p-47e posterior lead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00007 |
| MDR Report Key | 6370136 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 2007-08-14 |
| 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 | POSTERIOR LEAD |
| Product Code | PIM |
| Date Received | 2017-03-01 |
| Returned To Mfg | 2017-02-07 |
| Model Number | 2200P-47E |
| Catalog Number | 2200P-47E |
| Lot Number | C2-09269 |
| Device Expiration Date | 2008-02-01 |
| 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. Required No Informationntervention | 2017-03-01 |