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

Model Number	5156
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of the setscrew could not be turned to loosen it to remove the lead was confirmed.Final analysis revealed that calcified blood was filling the setscrew inset.The calcified blood was preventing the wrench from engaging the setscrew inset to untighten the setscrew.Wrenches cannot penetrate the calcified blood.The wrench can only strip portions of the inset it comes in contact with.The calcified blood was removed in the lab.Then a wrench could be inserted to engage the setscrew to untighten it.The stuck lead could then be removed from the connector.The blood came through a hole punched through the septum by the user of the torque wrench at time of implant.
Event or Problem Description
It was reported that the during generator change procedure, the set screw of the pacemaker (pm) was stripped, and the left ventricle (lv) lead was unable to be removed from the header of the pacemaker.The pacemaker was explanted and replaced with a new pacemaker on (b)(6) 2024.Additionally on (b)(6) 2024, the lv lead was capped and replaced with a new lead.The patient was stable throughout the procedure.

• Brand Name: VERITY ADX SR
• Common Device Name: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20595725
• Report Number: 2017865-2024-68869
• Device Sequence Number: 20474798
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: (01)05414734006767(10)2124105(17)090131
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Date: 01/31/2009
• Device Model Number: 5156
• Device Lot Number: 0002124105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/03/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 91 KG