Model Number 106 |
Device Problems
High impedance (1291); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Event Description
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Patient presented with high lead impedance and was referred for x-rays.The x-ray report indicated that the lead is continuous from the generator to the termination of the device at the base of the left neck.No discontinuity of the lead wire was seen.The x-ray images were not reviewed by the manufacturer.No known surgical intervention has occurred to date.No other relevant information has been received to date.
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Event Description
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X-ray images were received and reviewed.The generator was located in the patient¿s upper left chest below the 5th rib.The connector pin cannot be seen coming through the second connector block.The notches on the lead pin that are usually in the middle of the two connector blocks when fully inserted, are closer to the first connector block.The filter feedthru were confirmed to be intact.The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest.A strain relief bend and loop were both present per labeling.The tie-downs being present and placed per labelling could not be assessed due to the quality of the images provided.There was a portion of the lead that appeared to be routed behind the generator.The lead wires are intact at the connector pins.No sharp angles were identified in the visible portion of the lead.The lead could not be fully assessed for gross fractures or discontinuities due to the quality of the images provided.The cause of the patient¿s high impedance is due to incomplete pin insertion.Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.
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Event Description
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Additional information received noting that the patient underwent surgery and had their generator replaced.The surgeon did not try reinserting the lead pin as the patient's family requested the generator be replaced.All diagnostics tests with the newly implanted generator resulted in ok lead impedance.The explanted generator has not been received by product analysis to date.
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Search Alerts/Recalls
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