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

Model Number 5816

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

It was reported that during the procedure, the lead could not be inserted into the pacemaker.The pacemaker was removed and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported complaint of lead could not be inserted into the connector was confirmed.Analysis found the atrial (a)- and ventricular (v) -setscrews were down in the in the a- and v-connector ports blocking lead insertion.Analysis found the setscrews had been tightened down by a someone in the field.For analysis testing the setscrews were backed out from the blocking the ports.The is-1 leads could then be fully inserted into the connector ports.Normal insertion force was used to insert the leads.All connector dimensions were within specification.No device anomalies were found that would cause a lead insertion problem.The setscrews blocking the ports were caused by a user in the field.

• Brand Name: VICTORY XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11810453
• MDR Text Key: 250178802
• Report Number: 2017865-2021-17897
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: 05414734009553
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 5816
• Device Catalogue Number: 5816
• Device Lot Number: P000108228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1