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 Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested from the field.If additional information is received this report will be updated.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non boston scientific right ventricular (rv) lead exhibited jumpy pace impedance measurements of greater than 2,000 ohms, triggering a lead safety switch (lss).Technical services (ts) discussed troubleshooting options.The health care professional (hcp) was going to switch the patients next remote follow up to an in-office check to further evaluate.The device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the devices spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non boston scientific right ventricular (rv) lead exhibited jumpy pace impedance measurements of greater than 2,000 ohms, triggering a lead safety switch (lss).Technical services (ts) discussed troubleshooting options.The health care professional (hcp) was going to switch the patients next remote follow up to an in-office check to further evaluate.The device 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: 10908670
• MDR Text Key: 218647158
• Report Number: 2124215-2020-21333
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2020
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 738153
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR