BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U128 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting an is-1 lead into the header of this device.Please refer to the description for more information regarding the specific circumstances of this event.
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Event Description
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It was reported that during the implant procedure, difficulty was experienced inserting the right ventricular (rv) lead into the device header.The lead was able to be successfully inserted into the device header and the procedure was completed without further complication.No adverse patient effects were reported.
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Search Alerts/Recalls
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