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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 Incorrect Measurement (1383)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/20/2019
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 follow-up in clinic, the remaining estimated longevity was lower than expected.Technical support was contacted, and the longevity estimate was determined to be false.The device will be replaced at a later date and the patient was stable with no consequences.
 
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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 Key9419330
Report Number2017865-2019-17488
Device Sequence Number484634
Product Code DXY
UDI-Device Identifier05414734006811
UDI-Public05414734006811
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/05/2019
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 Date04/30/2008
Device Model Number5256
Device Lot Number2941984
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 11/20/2019
Initial Report FDA Received Date12/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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