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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5256
Medical Device Problem Code Data Problem (3196)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/22/2020
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
During a clinic follow-up, the device received an error message when measuring the lead parameter checks.Technical support was contacted, but no intervention has been performed at this time.The patient was in stable condition.
 
Event or Problem Description
Additional information was received that the device was explanted due to normal elective replacement indicator (eri).
 
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Brand Name
VERITY ADX XL
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key10802857
Report Number2017865-2020-17310
Device Sequence Number3799816
Product Code DXY
UDI-Device Identifier05414734006811
UDI-Public05414734006811
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/07/2020
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 Date03/31/2008
Device Model Number5256
Device Catalogue Number5256
Device Lot Number2941136
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/22/2020
Supplement Date Received by Manufacturer11/27/2020
Initial Report FDA Received Date11/06/2020
Supplement Report FDA Received Date12/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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