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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ASSURITY PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC. ASSURITY PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM1260
Medical Device Problem Code Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/06/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that the device went into backup vvi mode.Technical support was contacted and assisted with reprogramming the device to resolve the event.The patient was stable with no adverse consequences reported.
 
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Brand Name
ASSURITY PLUS
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
MDR Report Key8179548
Report Number2017865-2018-19197
Device Sequence Number1345646
Product Code LWP
UDI-Device Identifier05414734507080
UDI-Public05414734507080
Combination Product (Y/N)N
Initial Reporter CountryDA
PMA/510(K) Number
P970013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/19/2018
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 Health Professional
Device Expiration Date03/31/2016
Device Model NumberPM1260
Device Lot Number4802438
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/19/2018
Initial Report FDA Received Date12/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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