MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2272

Device Problems Intermittent Capture (1080); Mechanical Problem (1384); Connection Problem (2900)

Patient Problem Loss Of Pulse (2562)

Event Date 11/07/2018

Event Type  Injury  

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 Description

It was reported that the patient presented in the operating room for a scheduled procedure.After connecting the pacemaker, it was noted that the device was not capturing the ventricle properly, it has intermittent capture and long asystole was observed.The pocket was reopened and noted that the ventricular lead was not properly connected inside the connector boot.The physician tried to remove the ventricular lead from the pacemaker, but the set screw did not open very smoothly, and after several attempts the physician was able to disconnect the ventricular lead from the pacemaker.The threshold and impedance were good and in acceptable limit.The physician then re-connected the ventricular lead with the pacemaker but unable to fix the set screw.After several attempts the pacemaker was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported event of doctor had difficulty untightening the ventricular setscrew was confirmed.The analysis found the ventricular setscrew had been stuck in the v-connector block.The torque wrench that was used in the procedure had its hex tip twisted while trying to untighten setscrew which indicates the setscrew was stuck and required abnormal force to untighten it.Analysis was performed on both a and v connectors using scanning electron microscope, confirming the foreign material found in the a and v connector block threads to be epoxy, which caused the v setscrew to get stuck.When the setscrew was tightened on the lead during the implant procedure the epoxy in the threads caused the setscrew to be locked in place which prevented the removal of the lead.A manufacturing anomaly may have occurred that left or caused the epoxy to be in the connector block threads.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8074264
• MDR Text Key: 127262428
• Report Number: 2938836-2018-12219
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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: 01/31/2020
• Device Model Number: PM2272
• Device Lot Number: P000064141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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: 2088TC/58, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70