ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE
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Model Number 1457Q/86 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that when the patient presented in clinic for a follow up, left ventricular (lv) lead dislodgement was observed.The lead was explanted.The patient was stable.
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Manufacturer Narrative
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Analysis was normal.No anomalies were found.
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Search Alerts/Recalls
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