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

Model Number PM2282

Device Problem Failure to Disconnect (2541)

Patient Problem Pocket Erosion (2013)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

This mdr report product is for an ous event identified as same/similar during a retrospective review as a result of abbott¿s investigation.¿.

Event Description

Related manufacturer reference number: 2938836-2020-07724.Related manufacturer reference number: 2938836-2020-07725.It was reported the patient presented in clinic for follow-up with the pacemaker eroding.During explant, it was noted there was strong resistance when removing the right ventricular and atrial leads from the device.The physician opted to cut the leads and finish the explant.No patient consequences were reported.

• Brand Name: ZENEX 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15260147
• MDR Text Key: 298235415
• Report Number: 2017865-2022-19862
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140033
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: PM2282
• Device Lot Number: P000041749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2017
• 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
• Patient Outcome(s): Required Intervention