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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM1260
Medical Device Problem Code Data Problem (3196)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/03/2018
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 prior to implant, the patient's information was programmed onto the pacemaker.After a cybersecurity upgrade was performed on the device, the device was interrogated and no patient data appeared.The device was not used.No patient impact.
 
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Brand Name
ASSURITY PLUS
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key7692258
Report Number2017865-2018-10412
Device Sequence Number920410
Product Code LWP
UDI-Device Identifier05414734507080
UDI-Public05414734507080
Combination Product (Y/N)N
Initial Reporter CountryCA
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 Nurse
Type of Report Initial
Report Date (Section B) 07/16/2018
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 Date01/31/2019
Device Model NumberPM1260
Device Lot NumberP000047451
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 07/03/2018
Initial Report FDA Received Date07/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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