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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE MEDICAL MAESTRO RECHARGABLE SYSTEM; RECHARGABLE NEUROREGULATOR
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RESHAPE MEDICAL MAESTRO RECHARGABLE SYSTEM; RECHARGABLE NEUROREGULATOR Back to Search Results
Model Number 2002
Medical Device Problem Codes Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/26/2016
Type of Reportable Event Malfunction
Event or Problem Description
The device was implanted on (b)(6) 2016.The rnr had a flashing red light during implantation, half-way through patient registration with the cp.The rnr was replaced and the case was successfully completed.
 
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Brand Name
MAESTRO RECHARGABLE SYSTEM
Common Device Name
RECHARGABLE NEUROREGULATOR
Manufacturer (Section D)
RESHAPE MEDICAL
2800 patton road
saint paul MN 55113
MDR Report Key7466433
Report Number3005025697-2018-00006
Device Sequence Number159522
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
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/26/2018
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 Physician
Device Expiration Date03/02/2017
Device Model Number2002
Device Catalogue Number2002
Device Lot Number093G13315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2016
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/26/2016
Initial Report FDA Received Date04/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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