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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U125
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Endocarditis (1834); Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191); Pericardial Effusion (3271)
Event Date 11/06/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced an infection and endocarditis.An echocardiogram was performed, and vegetation was seen on the leads.Subsequently, a revision procedure was performed.It was noted that during the beginning of the procedure there was a trace of a pericardial effusion, however, the pericardial space was monitored and there was no change during the entire procedure.The right ventricular (rv) lead fragmented during the removal process; however, the entire rv lead was successfully removed.The crt-p, left ventricular (lv) lead, non-boston scientific right atrial (ra) lead, and non-boston scientific rv lead were successfully explanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced an infection and endocarditis.An echocardiogram was performed, and vegetation was seen on the leads.Subsequently, a revision procedure was performed.It was noted that during the beginning of the procedure there was a trace of a pericardial effusion, however, the pericardial space was monitored and there was no change during the entire procedure.The right ventricular (rv) lead fragmented during the removal process; however, the entire rv lead was successfully removed.The crt-p, left ventricular (lv) lead, non-boston scientific right atrial (ra) lead, and non-boston scientific rv lead were successfully explanted.No additional adverse patient effects were reported.
 
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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
MDR Report Key11234050
MDR Text Key228839273
Report Number2124215-2021-02315
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 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/15/2021
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number712757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Date Manufacturer Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
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