Model Number 4543 |
Device Problems
Failure to Capture (1081); Fracture (1260); High impedance (1291); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2023 |
Event Type
Injury
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Event Description
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It was reported that there were concerns of lead fracture for this left ventricular (lv) lead as it exhibited high out of range impedance measurements and failure to capture.Boston scientific technical services provided confirmation on the fracture.This lead remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that there were concerns of lead fracture for this left ventricular (lv) lead as it exhibited high out of range impedance measurements and failure to capture.Boston scientific technical services provided confirmation on the fracture.This lead remains in service.No adverse patient effects were reported.Additional information was received, this lead was explanted and successfully replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, the lead was thoroughly analyzed.Visual inspection confirmed that the lead was returned in two segments severed approximately 260 mm from the terminal end.Visual inspection of the lead confirmed that the polyurethane insulation was damaged in two places.It was also noted that in multiple areas of the lead the coil was stretched.Detailed testing of the damaged insulation revealed the insulation in that area had become degraded at an accelerated rate, likely due to the patient's blood chemistry.The degradation then led to the observed damage.Subsequent testing noted both coils fractured located 60mm from the severed proximal end of the tip segment due to cyclic fatigue.
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Event Description
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It was reported that there were concerns of lead fracture for this left ventricular (lv) lead as it exhibited high out of range impedance measurements and failure to capture.Boston scientific technical services provided confirmation on the fracture.This lead remains in service.No adverse patient effects were reported.Additional information was received, this lead was explanted and successfully replaced.No additional adverse patient effects were reported.Upon receipt at our post market quality assurance laboratory, the lead was thoroughly analyzed.Visual inspection confirmed that the lead was returned in two segments severed approximately 260 mm from the terminal end.Visual inspection of the lead confirmed that the polyurethane insulation was damaged in two places.It was also noted that in multiple areas of the lead the coil was stretched.Detailed testing of the damaged insulation revealed the insulation in that area had become degraded at an accelerated rate, likely due to the patient's blood chemistry.The degradation then led to the observed damage.Subsequent testing noted both coils fractured located 60mm from the severed proximal end of the tip segment due to cyclic fatigue.
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Search Alerts/Recalls
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