MEDTRONIC HEART VALVES DIVISION STREAMLINE BIPOLAR TEMPORARY 6495 PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY
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Model Number 6495 |
Device Problems
Break (1069); Disconnection (1171)
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Patient Problem
Loss of consciousness (2418)
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Event Date 02/06/2019 |
Event Type
Injury
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Event Description
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An elderly female with history of diabetes, atrial fibrillation had mitral valve replacement, tricuspid valve repair, clipping of left atrial appendage and left side cryo-maze with placement of atrioventricular pacer wires for severe mitral valve stenosis, severely dilated tricuspid valve annulus.The next day during the 3a-3p shift, patient was sitting on the side of the bed, and went unconscious, falling back on the bed.It was then discovered that the pacing wire disconnected from gray cables causing the patient to lose heart rhythm and consciousness for about 40 seconds as she was pacer dependent post op.She received no meds, cpr or compressions.When wire was attempted to be placed back into connector, it was found to be too short and broken off.Nurse manually held the wire in the connector for about 15 minutes until the electrophysiology physician could come and see the patient.The physician adjusted the wire and secured it with tape.Patient scheduled for permanent pacer placement the next day.It is not known whether the post was not fully inserted into the cable and it broke off or if it was fully inserted but had been tightened too tight to cause it to break.Please see photos for the size of the broken piece.We have no identifying product information from the device, as all packaging discarded.
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Event Description
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An elderly female with history of diabetes, atrial fibrillation had mitral valve replacement, tricuspid valve repair, clipping of left atrial appendage and left side cryo-maze with placement of atrioventricular pacer wires for severe mitral valve stenosis, severely dilated tricuspid valve annulus.The next day during the 3a-3p shift, patient was sitting on the side of the bed, and went unconscious, falling back on the bed.It was then discovered that the pacing wire disconnected from gray cables causing the patient to lose heart rhythm and consciousness for about 40 seconds as she was pacer dependent post op.She received no meds, cpr or compressions.When wire was attempted to be placed back into connector, it was found to be too short and broken off.Nurse manually held the wire in the connector for about 15 minutes until the electrophysiology physician could come and see the patient.The physician adjusted the wire and secured it with tape.Patient scheduled for permanent pacer placement the next day.It is not known whether the post was not fully inserted into the cable and it broke off or if it was fully inserted but had been tightened too tight to cause it to break.Please see photos for the size of the broken piece.We have no identifying product information from the device, as all packaging discarded.
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