MAUDE Adverse Event Report: ST. JUDE MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1258T

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  malfunction  

Event Description

A call to technical services was made on (b)(6) 2013 stating that this lead was experiencing intermittent diaphramatic stimulation while patient was lying flat as reported on a visit last (b)(6) 2013.Patient was programmed at 3.0v@1.0ms.Representative could recreate the stimulation with outputs at 3.0v@1.0ms but could not recreate with any output less than that.The lv threshold was at 1.0v@ 1 ms.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17524140
• MDR Text Key: 321425992
• Report Number: MW5131087
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1258T
• Patient Sequence Number: 1