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

Model Number U125

Device Problems High impedance (1291); Over-Sensing (1438); Pocket Stimulation (1463); Device Sensing Problem (2917)

Patient Problem Muscle Stimulation (1412)

Event Date 06/01/2018

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out-of-range pace impedance of greater than 3,000 ohms on the non-boston scientific left ventricular (lv) lead which resulted in an lead safety switch (lss).Once in the unipolar configuration, the patient reported diaphragmatic stimulation from lv pacing.Additionally, there were a couple of high pace impedance measurements on the right ventricular (rv) lead, though these measurements were still within the normal range.The health care professional (hcp) elected to leave the lv lead programmed to pace and sense from the lv tip to the rv and to program the lss to off.This product remains in service.No adverse patient effects were reported.

Event Description

Additional information was received that surgical intervention was done to replace the right ventricular (rv) lead of this cardiac resynchronization therapy pacemaker (crt-p) system.The rv lead was surgically abandoned.The crt-p remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 04:39 pm ct.The report number is being corrected from: 2124215-2018-62279to: 2124215-2018-60176.

Event Description

This report is being submitted due to an updated conclusion code provided from trend analysis.

Event Description

Additional information was received that spikes in impedance measurements had occurred on all three leads of this crt-p system: the right atrial (ra), right ventricular (rv), and left ventricular (lv) leads.Each lead had one or more impedance measurement that was high and out-of-range at greater than 2,000 ohms.After the lead safety switch (lss) that was formerly reported on the lv lead occurred, an x-ray was taken.It did not appear that the lead had dislodged or migrated.A lead safety switch (lss) also occurred on the rv lead.Following the lss on the rv lead, there was noise and oversensing on the rv lead.The patient is pacemaker dependent.Isometrics were done in office and some variations in impedance were seen, but the out-of-range measurements were not able to be reproduced.Boston scientific technical services (ts) recommended programming all leads to unipolar pacing and bipolar sensing.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: 8002755
• MDR Text Key: 124960872
• Report Number: 2124215-2018-60176
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2018
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 704210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 12/07/2018; 02/26/2019; 03/06/2019
• Supplement Dates FDA Received: 01/24/2019; 03/15/2019; 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR