It was reported that high lead impedance was found while the patient was in the clinic and suspected to be a lead break.
Output current was stated to be low.
Patient had consult with surgeon and scheduled lead revision surgery.
Information was received confirming the revision surgery took place.
It was stated that during the replacement case, the lead pin was found in the generator cavity and the silicone portion of the lead was detached from the lead pin.
Surgeon located the generator and found that it was not attached to the lead.
Both the generator and lead were replaced.
It was stated both the generator and lead would be sent back for analysis, but has not been received to date.
It was stated that the wires were not abraded and was a clean detachment from the pin.
It was also stated that there was no known trauma to the area and physician does not know what could have caused this.
No additional relevant information has been received to date.
|