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

Model Number PM2272

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2018

Event Type  malfunction  

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 non pacer dependent patient presented for routine generator change out procedure.When physician attempted to connect the atrial lead with new device, the lead would go all the way in but the setscrew could not be tightened down.The lead was tested with a second and third device and the same issue occurred.The lead was successfully reinserted into the explanted generator.Upon another attempt, the physician successfully inserted the lead into the first attempted device and lead parameters were in range.Patient was stable before, during, and after the procedure and will continue to be monitored.

Manufacturer Narrative

The reported complaint of the atrial lead could not be fully inserted in the connector was confirmed.The setscrew showed some damage from incorrect attempts to insert the wrench into the setscrew inset.The problem was most likely related to the user of the wrench in the field.The device was tested on the bench and no anomalies were found.The returned torque wrenches were found normal.

• Brand Name: ASSURITY MRI
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7186711
• MDR Text Key: 97138823
• Report Number: 2017865-2018-00650
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

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: 04/30/2019
• Device Model Number: PM2272
• Device Lot Number: A000049734
• Other Device ID Number: 05414734509589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 04/23/2018
• Supplement Dates FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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: PM2240, (B)(4)
• Patient Age: 85 YR
• Patient Weight: 88