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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VERITY ADX XL VDR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT VERITY ADX XL VDR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5456I
Medical Device Problem Code Battery Problem: High Impedance (2947)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/27/2020
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 remote follow-up, increased battery impedance was observed on the device.Technical support was contacted and recommended a firmware download to resolved the event.No intervention has been performed at this time.The patient was stable and will continue to be monitored.
 
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Brand Name
VERITY ADX XL VDR
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key10551363
Report Number2017865-2020-13739
Device Sequence Number3135054
Product Code DXY
UDI-Device Identifier05414734010474
UDI-Public05414734010474
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/17/2020
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 Date07/31/2014
Device Model Number5456I
Device Catalogue Number5456i
Device Lot Number3917755
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 09/03/2020
Initial Report FDA Received Date09/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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