MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) VERITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5156

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Incorrect Measurement (1383); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); No Pacing (3268)

Patient Problems Arrhythmia (1721); Dizziness (2194)

Event Date 12/14/2020

Event Type  Injury  

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 Description

It was reported that a patient presented to hospital with lightheadedness, dizziness, and symptomatic complete heart block.The device longevity estimates went from several years to few months until end of life.Clinician was unable to interrogate the device or obtain a magnet response.No capture or pacing spikes were seen on surface strips.Possibility of outside interference and false elective replacement indicator (eri)/end of life (eol) were suggested as possible issues.The device was explanted and replaced.The patient was stable.

• Brand Name: VERITY ADX SR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11074453
• MDR Text Key: 223707206
• Report Number: 2017865-2020-23619
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: 05414734006767
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: 5156
• Device Catalogue Number: 5156
• Device Lot Number: 3164482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention