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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 Problem Insufficient Information (4580)
Event Date 01/27/2021
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out-of-range (oor) pacing impedances measuring greater than 2000 ohms on the non-boston scientific right ventricular (rv) lead.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.It was also noted there was a gradual increase in impedances over the last year.This crt-p and non- boston scientific rv lead remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out-of-range (oor) pacing impedances measuring greater than 2000 ohms on the non-boston scientific right ventricular (rv) lead.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.It was also noted there was a gradual increase in impedances over the last year.This crt-p and non- boston scientific rv 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 Key11369756
MDR Text Key233248857
Report Number2124215-2021-04318
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 company representative
Type of Report Initial,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/29/2018
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number702186
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
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