ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES
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Model Number 7122Q/65 |
Device Problems
Failure to Capture (1081); Retraction Problem (1536); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient presented for a follow-up in clinic.Review of the device records noted high capture thresholds on the right ventricular (rv) lead which led to loss of capture.A chest x-ray performed noted a slight change in the position of the rv lead, leading the physician to suspect the rv lead was dislodged.The patient was asymptomatic.The physician tried repositioning the rv lead, but the helix failed to retract.The rv lead was explanted and replaced successfully.The patient is recovering.
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Manufacturer Narrative
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The reported events were lead dislodgement, helix mechanism issue and failure to capture.As received, a complete lead was returned in one piece with the helix found extended/bent and clogged with blood/tissue.The reported event of helix mechanism issue was confirmed.X-ray inspection found overtorque of the inner coil at the connector region consistent with procedural damage, and found that the helix stretched/bent, also consistent with procedural damage.The cause of the reported event of helix mechanism issue was isolated to blood/tissue and stretched/bent of the helix in the helix region and overtorqued of the inner coil.The reported event of failure to capture was not confirmed.Analysis was normal.No anomalies were found.
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Search Alerts/Recalls
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