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

Model Number	5056
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Disconnect (2541)
Health Effect - Clinical Codes	Syncope (1610); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2020
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
Related manufacturer reference number: 2017865-2020-04721.It was reported that the patient presented at a follow-up in clinic with syncope.Upon interrogation, the right ventricular lead exhibited high pacing impedance.The physician capped and replaced the lead on (b)(6) 2020.During procedure, the right ventricular lead was unable to be removed from the header of the pacemaker.The physician cut out the lead and explanted and replaced the pacemaker.The patient was in stable condition.
Additional Manufacturer Narrative
The pacemaker was returned for the reported event of unable to loosen the setscrew to release the right ventricular lead.Analysis found that multiple pieces of the septum were torn and punched out by the torque wrench, landing in the setscrew inset.The excess material from the stripped setscrew made it not possible to be engaged by the torque wrench.No other anomalies were noted.The reported event was confirmed and attributed to procedural damage.

• Brand Name: VERITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9932137
• Report Number: 2017865-2020-04720
• Device Sequence Number: 10906113
• Product Code: DXY
• UDI-Device Identifier: 05414734006712
• UDI-Public: 05414734006712
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2021

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: 10/31/2016
• Device Model Number: 5056
• Device Catalogue Number: 5056
• Device Lot Number: P000007094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 02/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ISOFLEX OPTIM LEAD; ISOFLEX OPTIM LEAD
• Patient Age: 68 YR
• Patient Weight: 55