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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 2002
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/09/2016
Type of Reportable Event Malfunction
Event or Problem Description
While interrogating the rechargeable neuroregulator device prior to implant, a red status led was displayed when attempting to check the battery status.The error condition was checked which indicated a magnet swipe shutdown had occurred.The field clinician engineer decided not use this device and proceeded with a back up unit.
 
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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 Key7176223
Report Number3005025697-2018-00001
Device Sequence Number1407716
Product Code PIM
UDI-Device Identifier00857334004262
UDI-Public00857334004262
Combination Product (Y/N)N
Initial Reporter StateMN
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 Other
Type of Report Initial
Report Date (Section B) 01/09/2018
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 Medical Equipment Company Technician/Representative
Device Expiration Date12/10/2016
Device Model Number2002
Device Catalogue Number2002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2016
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/09/2016
Initial Report FDA Received Date01/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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