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

Model Number PM2272

Device Problems Connection Problem (2900); Device Sensing Problem (2917); Impedance Problem (2950); Output Problem (3005)

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

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 for a pacemaker device check in (b)(6) 2018.Upon interrogation of the device, it was discovered that the atrial lead exhibited fluctuating impedances, capture threshold, and sensing in both bipolar and unipolar configurations.There were no anomalies noted during post implant check of the device back in (b)(6) of 2018.An x-ray was taken in the month prior which showed the atrial lead pin was inserted fully into the pacemaker header.On (b)(6) 2018, the patient presented for a lead revision procedure.After the pocket was opened, the surgeon tugged the atrial lead slightly and the lead came out of the atrial port with ease.It was then determined that the set screw had not been properly fastened.The lead was re-inserted into the atrial port and set screw was tightened.All lead electrical measurements returned to normal.Additional lead and pocket manipulation was tested and the lead electrical measurements remained in normal range with little to no variance.The patient was reported to be in stable condition prior to and post procedure.

• 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: 7950031
• MDR Text Key: 123190098
• Report Number: 2017865-2018-15069
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• 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
• Report Date: 10/09/2018

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: 11/30/2019
• Device Model Number: PM2272
• Device Lot Number: A000056830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2018
• 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
• Patient Outcome(s): Required Intervention