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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC. VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5256
Medical Device Problem Code Misconnection (1399)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/13/2018
Type of Reportable Event Malfunction
Event or Problem Description
During device replacement due to normal eri, the set screw was unable to be withdrawn due to being stripped.The issue was resolved by cutting the lead and replacing the device and lead.The patient was in stable condition and experienced no adverse health consequences.
 
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Brand Name
VERITY ADX XL
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
MDR Report Key7685889
Report Number2017865-2018-10260
Device Sequence Number19003710
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 Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/13/2018
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 Date05/31/2007
Device Model Number5256
Device Lot Number2992240
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 06/26/2018
Initial Report FDA Received Date07/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNKNOWN LEAD MODEL NUMBER, UNKNOWN SERIAL NUMBER
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