MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-01 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Enteromedics, Inc..
[61243795]
Device still implanted; not returned.
Patient Sequence No: 1, Text Type: N, H10
[61243796]
This patient was implanted with the maestro rechargeable system on (b)(6) 2016. Patient was unable to charge their rechargeable neuroregulator (rnr) for an extended period of time due to an issue with an external system component. This resulted in disconnection of the rnr battery and discontinuation of therapy. During a clinic visit to reconnect the rnr battery on (b)(6) 2016, a charge of the rnr battery could not be initiated. The rnr went from the application mode into the bootloader mode of operation and a brownout code was encountered. An unexpected response code (nak) was received. The rnr battery could not be reconnected and therapy could not be restarted.
Patient Sequence No: 1, Text Type: D, B5
[69404171]
This patient was implanted with the maestro rechargeable system on (b)(6) 2016. Patient was unable to charge their rechargeable neuroregulator (rnr) for an extended period of time due to an issue with an external system component. This resulted in disconnection of the rnr battery and discontinuation of therapy. During a clinic visit to reconnect the rnr battery on (b)(6)2016, a charge of the rnr battery could not be initiated. The rnr went from the application mode into the bootloader mode of operation and a brownout code was encountered. An unexpected response code (nak) was received. The rnr battery could not be reconnected and therapy could not be restarted. Update: recharging was unsuccessfully attempted on (b)(6) 2016 in clinic with field clinical engineer. It was determined that charging was prevented due to an elevated baseline temperature of the rechargeable neuroregulator. Successful recharge of the rechargeable neuroregulator was achieved on (b)(6) 2016 using a procedure developed to recover a disconnected battery with a high baseline temperature. No rnr safety parameters were modified and it was ensured that maximum implant temperature during charging was below 42c in accordance with product specifications. Normal therapy delivery was resumed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2016-00014 |
| MDR Report Key | 6137999 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-01 |
| Date of Report | 2017-03-01 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2016-12-13 |
| Device Manufacturer Date | 2014-10-24 |
| 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 | RECHARGEABLE NEUROREGULATOR |
| Product Code | PIM |
| Date Received | 2016-12-01 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Lot Number | 093G29714 |
| Device Expiration Date | 2016-06-10 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2016-12-01 |