MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY + DR RF; Pulse generator, permanent, implantable

Model Number PM2260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pocket Erosion (2013); Discomfort (2330)

Event Date 03/27/2024

Event Type  Injury  

Event Description

It was reported, that the patient presented for a follow-up in clinic.With a pacemaker that had eroded through the skin.The patient felt something strange at the pocket site.The pacemaker was explanted.The patient was in stable condition.

• Brand Name: ASSURITY + DR RF
• Type of Device: Pulse generator, permanent, implantable
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19103137
• MDR Text Key: 340101928
• Report Number: 2017865-2024-38345
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507097
• UDI-Public: (01)05414734507097(10)S000027238(17)180531
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: PM2260
• Device Lot Number: S000027238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2016
• 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: INTERMEDICS ATRIAL LEAD; INTERMEDICS VENTRICULAR LEAD
• Patient Outcome(s): Required Intervention