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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENTEROMEDICS, INC. MAESTRO RECHARGEABLE SYSTEM; ANTERIOR LEAD
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ENTEROMEDICS, INC. MAESTRO RECHARGEABLE SYSTEM; ANTERIOR LEAD Back to Search Results
Model Number 2200A-47E
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/14/2017
Type of Reportable Event Malfunction
Event or Problem Description
High impedance of the anterior lead was experienced during an initial implant procedure of the maestro rechargeable system in this patient.The anterior lead was replaced during the same procedure resulting in impedance values within the acceptable range and successful activation of therapy.The initial anterior lead that resulted in high impedance measurements was returned for analysis.
 
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Brand Name
MAESTRO RECHARGEABLE SYSTEM
Common Device Name
ANTERIOR LEAD
Manufacturer (Section D)
ENTEROMEDICS, INC.
2800 patton road
saint paul MN 55113
MDR Report Key6798628
Report Number3005025697-2017-00016
Device Sequence Number16336507
Product Code PIM
UDI-Device Identifier00857334004286
UDI-Public00857334004286
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 Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/16/2017
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 Date05/01/2020
Device Model Number2200A-47E
Device Catalogue Number2200A-47E
Device Lot NumberC4-12859
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2017
Initial Report FDA Received Date08/16/2017
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;
Patient Age54 YR
Patient Weight113
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