MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-18 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Enteromedics, Inc..
[90533531]
This patient was implanted with the maestro rechargeable system on (b)(6) 2017. This subject has reported issues charging the implanted rechargeable neuroregulator. Using a charged mobile charger, communication required for charging could not be maintained. Upon device interrogation, no alarms or error codes were noted. An alarm clearing sequence was run during a clinic visit on (b)(6) 2017. Following this, a charge was successfully initiated. Patient left the clinic receiving therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2017-00023 |
| MDR Report Key | 6958720 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-10-18 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2017-09-29 |
| Device Manufacturer Date | 2016-01-07 |
| Date Added to Maude | 2017-10-18 |
| 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 | RECHARGEABLE NEUROREGULATOR |
| Product Code | PIM |
| Date Received | 2017-10-18 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Lot Number | 093G00716 |
| Device Expiration Date | 2017-08-10 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-18 |