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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; IMPLANTABLE DEVICE Back to Search Results
Model Number U125
Device Problem High impedance (1291)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 12/01/2019
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead and left ventricular (lv) lead measuring greater than 3000 ohms.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.It was noted that an additional lss occurred a year ago and the respiratory rate trend feature was programmed off prior.Boston scientific technical services (ts) recommended to perform isometric testing and arm movements with serial impedances.Ts provided possible causes and provided programming options.At this time, this pacemaker and non-boston scientific rv and lv lead remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead and left ventricular (lv) lead measuring greater than 3000 ohms.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.It was noted that an additional lss occurred a year ago and the respiratory rate trend feature was programmed off prior.Boston scientific technical services (ts) recommended to perform isometric testing and arm movements with serial impedances.Ts provided possible causes and provided programming options.At this time, this pacemaker and non-boston scientific rv and lv lead remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead and left ventricular (lv) lead measuring greater than 3000 ohms.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.It was noted that an additional lss occurred a year ago and the respiratory rate trend feature was programmed off prior.Boston scientific technical services (ts) recommended to perform isometric testing and arm movements with serial impedances.Ts provided possible causes and provided programming options.At this time, this pacemaker and non-boston scientific rv and lv lead 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 device 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.
 
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Brand Name
VALITUDE CRT-P
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11104909
MDR Text Key224802052
Report Number2124215-2020-26069
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559389
UDI-Public00802526559389
Combination Product (y/n)N
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 04/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/27/2018
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number703052
Was Device Available for Evaluation? No
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age86 YR
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