Device Problems
High impedance (1291); Battery Problem (2885)
|
Patient Problem
No Code Available (3191)
|
Event Date 10/30/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that during generator replacement surgery due to end of service, the vns patient¿s replacement generator was connected with the existing lead and diagnostic results revealed high impedance.The surgeon reinserted the lead pin and subsequent tests showed lead impedance within normal limits.The procedure was completed but the patient device was tested again during recovery and high impedance was again observed.No tests could be performed prior to the procedure due to end of service condition.X-rays were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.Portions of the lead were unable to be assessed due to the quality of the images provided.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, the cause of the high lead impedance remains unknown.No known surgical interventions for the high impedance have occurred to date.
|
|
Event Description
|
The arrangement of the electrodes could not be assessed.Additional information was received stating that the vns patient¿s device should lead impedance within normal limits (impedance value ¿ 2543 ohms) during an office visit prior to generator replacement on (b)(6) 2014.Patient manipulation or trauma is not believed to have caused or contributed to the high impedance.The patient¿s device was disabled following the high impedance observation.
|
|
Event Description
|
It was reported that lead revision surgery was planned.It was later confirmed that the intervention was completed on 02/05/2015.The explanted lead has not been returned to date.
|
|
Manufacturer Narrative
|
Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Device failure is suspected, but did not cause or contribute to a death or serious injury.
|
|
Manufacturer Narrative
|
Describe event or problem; corrected data: the previously submitted mdr inadvertently stated that the electrodes were in correct arrangement when actually the arrangement of the electrodes could not be assessed.
|
|
Search Alerts/Recalls
|