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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Heartburn/Indigestion (1883)
Date of Event 04/19/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The device was removed on (b)(6) 2019 after the patient experienced symptoms of indigestion and heartburn.
 
Event or Problem Description
The device was removed on (b)(6) 2019 after the patient experienced symptoms of indigestion and heartburn.
 
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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 Key8604095
Report Number3005025697-2019-00002
Device Sequence Number11342643
Product Code PIM
UDI-Device Identifier00857334004347
UDI-Public00857334004347
Combination Product (Y/N)N
Initial Reporter StateDE
Initial Reporter CountryUS
PMA/510(K) Number
P130019
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date (Section B) 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number2002
Device Catalogue Number2002
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/24/2019
Supplement Date Received by Manufacturer04/24/2019
Initial Report FDA Received Date05/13/2019
Supplement Report FDA Received Date12/19/2019
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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