MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX OPTIM LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1948/52

Device Problems Break (1069); Intermittent Capture (1080); Kinked (1339); Over-Sensing (1438); Difficult to Remove (1528); High Capture Threshold (3266)

Patient Problem Syncope (1610)

Event Date 05/31/2017

Event Type  Injury  

Event Description

It was reported that the device dependent patient experienced syncopal episodes due to high impedance on the right ventricular lead.Upon interrogation of the device, noise and intermittent capture were noted.An x-ray was performed and showed that the lead was kinked and appeared to be crushed.The lead was not able to be explanted so it was capped and replaced on (b)(6) 2017.During the procedure, the right atrial lead appeared to had been crushed as well.The atrial lead was extracted and replaced.The patient is stable.

• Brand Name: ISOFLEX OPTIM LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6623246
• MDR Text Key: 77019886
• Report Number: 2017865-2017-04706
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960030
• 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: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: 1948/52
• Device Lot Number: P000015864
• Other Device ID Number: 05414734502344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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: 1882TC/46, CWE023472
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR