MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problem High impedance (1291)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 01/02/2019

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and other manufacturer leads have had observations of intermittent jumps in impedances, where the right ventricular (rv) lead had recently triggered a lead safety switch for high out of range impedances.There were no episodes or noise stored before the safety switch occurred.The device system remains in-service.No additional adverse patient effects were reported.

Event Description

Additional report was sent with updated conclusion code.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and other manufacturer leads have had observations of intermittent jumps in impedances, where the right ventricular (rv) lead had recently triggered a lead safety switch for high out of range impedances.There were no episodes or noise stored before the safety switch occurred.The device system remains in-service.No additional adverse patient effects were reported.Additional information was received that there was another rv lead safety switch due to ongoing intermittent high out-of-range jumps in impedances.The left ventricular (lv) lead also showed measurement for high out-of-range impedances on this safety switch due to being programmed with rv ring.Technical services suggested to keep the respiratory rate trend feature turned off and find a lv pacing configuration that does not use the rv ring to mitigate future lv impedance correlation.This system remains in-service.No adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8504353
• MDR Text Key: 141613894
• Report Number: 2124215-2019-03331
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 717487
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Age: 73 YR