MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number U125

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917); High Capture Threshold (3266)

Patient Problems Non specific EKG/ECG Changes (1817); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2018

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited jumpy impedance measurements on both the non-boston scientific right ventricular (rv) and left ventricular (lv) leads.The impedances varied between 450 ohms and 1,250 ohms, still within the normal range.Subsequently, the impedance on both leads steadily increased to around 1,600 ohms.The rv and lv leads also exhibited noise, oversensing, and loss of capture (loc).The oversensing resulted in some pacing inhibition.The cause of the clinical observations could not be determined but a spring contact issue between the leads and header was suspected.The rv lead was reprogrammed to unipolar pacing and the lv lead was programmed to pace/sense from ring to can.It was also noted that there were two spikes in impedance on the non-boston scientific right atrial (ra) lead.The impedance spikes were high and out-of-range, greater than 2,000 ohms.Subsequently, the ra impedance has been stable and within range.This product remains in service.No adverse patient effects were reported.

Event Description

This report is being filed because an updated conclusion code was provided based on trend analysis.

Event Description

Additional information was received that another episode with noise occurred on this cardiac resynchronization therapy pacemaker (crt-p) system.The patient also reported being symptomatic.The noise resulted in oversensing and pacing inhibition that caused about a 3 second pause.Boston scientific technical services (ts) reviewed all of the available data and suggested that this may be a lead integrity issue; however, no further action was taken to determine cause at this time.The physician elected to continue monitoring.The crt-p was reprogrammed to ddd mode and the right ventricular (rv) sensitivity was lowered.This product remains in service.No adverse patient effects were reported.

• Brand Name: VALITUDE CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8016351
• MDR Text Key: 125438207
• Report Number: 2124215-2018-60624
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2019
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 705981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR