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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR,
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RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR, Back to Search Results
Model Number P01367-001
Medical Device Problem Code Low impedance (2285)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 06/20/2019
Type of Reportable Event Malfunction
Event or Problem Description
Patient observed a red light on the mobile charger and was unable to charge device.The patient reached out to the clinical site to schedule a visit.Upon communication with device using the clinical programmer, error code 4 was observed, "too many therapy retries".Patient will be going to the office for a visit on (b)(6) 2019 to have the log files downloaded onto a usb drive.Errors are due to low impedance on the device leads.
 
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Brand Name
MAESTRO RECHARGEABLE SYSTEM
Common Device Name
RECHARGEABLE NEUROREGULATOR,
Manufacturer (Section D)
RESHAPE LIFESCIENCES
2800 patton road
saint paul MN 55113
MDR Report Key8802628
Report Number3005025697-2019-00005
Device Sequence Number18913833
Product Code PIM
UDI-Device Identifier00857334004347
UDI-Public00857334004347
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P130019
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberP01367-001
Device Catalogue NumberMC MODEL 2402, US
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/20/2019
Initial Report FDA Received Date07/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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