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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VICTORY XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT VICTORY XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5610
Medical Device Problem Code Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/23/2020
Type of Reportable Event Serious Injury
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
During an in clinic follow-up, the device was found to have entered backup vvi (bvvi) mode.Upon further investigation, the device was found to have reached the elective replacement indicator (eri) which was suspected to have caused the device to enter bvvi mode.Device replacement is anticipated to address the normal eri.The patient was stable and will continue to be monitored.
 
Event or Problem Description
Additional information received indicated the device was explanted and replaced to resolve the event.The patient was in stable condition.
 
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Brand Name
VICTORY XL SR
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key10793053
Report Number2017865-2020-17217
Device Sequence Number3657274
Product Code LWP
UDI-Device Identifier05414734009539
UDI-Public05414734009539
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/17/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date03/31/2013
Device Model Number5610
Device Catalogue Number5610
Device Lot Number3494306
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/23/2020
Supplement Date Received by Manufacturer11/13/2020
Initial Report FDA Received Date11/05/2020
Supplement Report FDA Received Date11/17/2020
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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