MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY¿ CORE DR, MRI (US); implantable pacemaker Pulse-generator

Model Number PM2140

Device Problems Failure to Interrogate (1332); No Pacing (3268)

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

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Further information was requested, but not received.

Event Description

Related manufacturer reference number: (b)(4), related manufacturer reference number: (b)(4).It was reported, that the patient presented to the clinic for a scheduled follow up.Upon interrogation of the pacemaker, the right ventricular (rv) and right atrial (ra) leads were found to have exhibited failure to capture.The physician elected for the rv and ra leads to be replaced.Prior to the procedure, the pacemaker could not be interrogated.And had no low voltage output, during the procedure.The pacemaker, rv and ra leads were all explanted and replaced.The patient was in stable condition throughout.

Manufacturer Narrative

The reported events of no output and inability to interrogate were confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested, resulting in high current drain, consistent with moisture damage, depleting the battery and resulting in the reported events.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.

• Brand Name: ENDURITY¿ CORE DR, MRI (US)
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18708309
• MDR Text Key: 335403288
• Report Number: 2017865-2024-22702
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: PM2140
• Device Lot Number: P000102654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• 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