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

Model Number 5626

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Discomfort (2330)

Event Date 11/10/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2021-37946.It was reported that the patient complained of pocket pain.It was noted that the pacemaker had migrated slightly and was not sutured down in the pocket by the implanting physician.The patient presented for pocket revision.Once the pocket was open, the physician noticed lead insulation breaks and breaches at the proximal end of the right ventricular lead.There was another area still in the pocket more distal from the connector pin that appeared to look like damage from lead-can abrasion.The physician replaced the device and elected to manually repair the lead with two suture sleeves and medical adhesives.There was no concern of lead performance.The patient was stable post procedure.

Manufacturer Narrative

Correction: h6 - 1395 - migration or expulsion of device should have been included.

• Brand Name: ZEPHYR XL 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: 12899024
• MDR Text Key: 281502985
• Report Number: 2017865-2021-37945
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501712
• UDI-Public: 05414734501712
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2010
• Device Model Number: 5626
• Device Catalogue Number: 5626
• Device Lot Number: 2753046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 11/30/2021; 01/19/2022
• Supplement Dates FDA Received: 11/30/2021; 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2009
• 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
• Treatment: TENDRIL ST
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female