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

Model Number U128

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) declared a lead safety switch (lss) due to high out-of-range (oor) pacing impedances on the right ventricular (rv) lead, measuring greater than 2000 ohms.After the lss, noise and oversensing occurred, which resulted in pacing inhibition.The patient experienced greater than 2 seconds of asystole.The patient's rv lead was a non-boston scientific product.Troubleshooting was performed and the noise was reproduced with isometrics in the unipolar but not in the bipolar configuration.The lss feature was programmed off and the rv lead was reprogrammed to bipolar.Subsequently, another oor impedance alert occurred.Boston scientific technical services (ts) discussed the impedance spikes could be due to intermittent ring contact in the head.Ts recommended reprogramming to bipolar sense and unipolar pace.This crt-p remains in service.No adverse patient effects were reported.

Event Description

This supplemental report is being filed as the conclusion code was updated.

• 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: 8546038
• MDR Text Key: 142956332
• Report Number: 2124215-2019-07563
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/08/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 714936
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR