Patient age, date of birth, gender and weight are unavailable.The device and lead were returned to the manufacturer for evaluation.The device was still locked within the lead upon receipt to the manufacturer.Visual inspection of the device found evidence of the lead being compromised.It is probable that the age of the lead contributed to the degradation in integrity.No evidence was observed to indicate that the lld device malfunctioned to cause this event.
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It was reported that during a lead extraction procedure, the lld device protruded from the end of the lead.Reportedly, it was initially difficult to advance the lld to the tip of the lead.A stiff stylet was used to advance further into the lead, and clearing stylet was used to advance fully to the tip.The lld was then re-inserted to a more distal portion of the lead than before.Fluoroscopy was then used to confirm placement.The physician reportedly felt that the deployment mechanism had locked and that there was an abnormal amount of slack in the lld.On fluoroscopy, it was identified that the fluoro marker and interior mandrel of the device were deployed past the tip of the lead.The locking mechanism was stable despite this fact, and the lead was successfully extracted with the aid of a visisheath device.The patient was not affected.
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