SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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Model Number PARADYM VR 8250 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2014 |
Event Type
Injury
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Event Description
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Reportedly, during the implantation procedure, the lead could not be tightened properly although the ratchet noise was heard on the distal df-1 connector level.Two other screwdrivers were used, the same behavior had occurred yet again.An attempt to insert the same lead on the svc level was successful.Another device was successfully implanted with the same lead.An explanation is required.
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Event Description
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Reportedly, during the implantation procedure, the lead could not be tightened properly although the ratchet noise was heard on the distal df-1 connector level.Two other screwdrivers were used, the same behavior had occurred yet again.An attempt to insert the same lead on the svc level was successful.Another device was successfully implanted with the same lead.An explanation is required.
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