During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.Date of event is estimated.Additional components potentially involved in the event include: common device name: scs lead, model: 3186, udi: (b)(4), serial: n/a, batch: 3590764.
|
It was reported that one of the leads was showing high impedance.It was found that the lead had been fractured.In turn, surgical intervention was undertaken wherein the lead was explanted and replaced.Postoperatively, the patient has effective therapy.Note: investigation did not determine which lead was fractured.
|
During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|