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

Model Number PM2272

Device Problem Separation Failure (2547)

Patient Problems Cardiomyopathy (1764); No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2020

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.Further information was requested but not received.

Event Description

It was reported that the patient presented for an elective replacement procedure.During the procedure it was noted that the patient's lead had difficulty being removed from the right ventricular port on the device header.The device was successfully replaced.The patient's condition was stable throughout the event.

Event Description

New information noted that the patient presented for the elective replacement procedure due to right ventricular induced cardiomyopathy.It was suspected that the patient's cardiomyopathy was related to the right ventricular pacing on the patient's pacemaker.

Manufacturer Narrative

The reported field event of the difficulty removing the rv-lead from the pacer connector port was confirmed.Analysis found blood throughout the connector port area that can cause resistance to lead removal.The blood was most likely not cleaned from the lead connector areas before inserting it into the device connector port during the implant procedure.The device was tested on the bench using automated testing equipment and no anomalies were found.

• 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
• MDR Report Key: 9795645
• MDR Text Key: 182287432
• Report Number: 2017865-2020-03150
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000045111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR