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); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 06/24/2018

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced a heart rate of 30 beats per minute (bpm) for 45 seconds.It was noted after the 45 seconds of pacing inhibition the patients rate returned to normal.There was noise on the right ventricular (rv) lead and left ventricular (lv) lead, however, it was not oversensed.The patient's rv lead is a non-boston scientific product.In addition, there was a small spike in pacing impedances on the rv and lv leads.Isometrics and pocket manipulation was performed and the noise was not recreated.Boston scientific technical services (ts) the lv lead is programmed to pace to the rv lead ring so there could be a possible ring electrode issue on the rv lead.The lv lead was reprogrammed.Subsequently, a revision procedure was performed.The crt-p and rv lead were explanted and replaced.The lv lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported high impedances, noise, and pacing inhibition.

Event Description

This supplemental report is being filed as the device evaluation was completed.

• 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: 8510885
• MDR Text Key: 141811787
• Report Number: 2124215-2019-05438
• 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
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 719952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 91 YR