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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 Failure to Interrogate (1332)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/13/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event or Problem Description
During a follow-up in clinic, the device was unable to be interrogated with several programmers.The device was explanted and replaced.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 Key9125652
Report Number2017865-2019-14233
Device Sequence Number14085366
Product Code LWP
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
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/17/2019
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 Date03/04/2006
Device Model Number5256
Device Lot Number2994480
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/13/2019
Supplement Date Received by Manufacturer09/13/2019
Initial Report FDA Received Date09/26/2019
Supplement Report FDA Received Date10/17/2019
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 Hospitalization; Required Intervention;
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