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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U125
Device Problems High impedance (1291); Impedance Problem (2950)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2020
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non-boston scientific right ventricular (rv) lead exhibited high out-of-range pace impedance measurements greater than 2,000 ohms.Also exhibited were variances or spikes in the non-boston scientific right atrial (ra) lead pace impedance measurements, ranging from 400 ohms to the 1,500 ohms range.Technical services (ts) discussed spring contact issues with non-bsc leads and troubleshooting options.The device 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's 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.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non-boston scientific right ventricular (rv) lead exhibited high out-of-range pace impedance measurements greater than 2,000 ohms.Also exhibited were variances or spikes in the non-boston scientific right atrial (ra) lead pace impedance measurements, ranging from 400 ohms to the 1,500 ohms range.Technical services (ts) discussed spring contact issues with non-bsc leads and troubleshooting options.The device remains in service.No adverse patient effects were reported.
 
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Brand Name
VALITUDE 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 Key10714604
MDR Text Key212387776
Report Number2124215-2020-21334
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
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/27/2020
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number711521
Was Device Available for Evaluation? No
Date Manufacturer Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age89 YR
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