BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
|
Back to Search Results |
|
Model Number U128 |
Device Problem
High impedance (1291)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/28/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right ventricular (rv) lead, exhibited high out-of-range pace impedance measurements greater than 2,000 ohms.Additional information received indicated that the patient was seen in clinic and the decision was made to continue monitoring the device to see if action was needed at a later date.This crt-p remains in service.No additional adverse patient effects were reported.
|
|
Event Description
|
It was reported that that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right ventricular (rv) lead, exhibited high out-of-range pace impedance measurements greater than 2,000 ohms.Additional information received indicated that the patient was seen in clinic and the decision was made to continue monitoring the device to see if action was needed at a later date.This crt-p remains in service.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|