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
Difficult to Remove (1528); 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 09/14/2023 |
Event Type
Injury
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Event Description
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Related manufacturer reference numbers: 2017865-2023-47562.It was reported that the patient presented in clinic for follow-up.Upon chest x-ray examination, it was found that the right ventricular (rv) lead had dislodged.During rv lead repositioning procedure, it was found that the rv lead helix failed to be retracted, and the rv lead was unable to be disconnected from the implantable cardioverter defibrillator (icd).Both the icd and the rv lead were explanted and replaced.There were no patient consequences.
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Manufacturer Narrative
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The reported event of helix mechanism issue was confirmed., but the reported event of lead difficult to remove was not confirmed.A full lead was returned in one piece for analysis.Specification measurements and visual inspection were normal.X-ray examination found over-torqued of the inner coil at the connector region consistent with procedural damage.The cause of helix mechanism issue was isolated to the helix being clogged with dried blood, blood on the inner coil, and over-torqued of the inner coil.No other anomalies were found.
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