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

Model Number U125

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problem Dizziness (2194)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the patient presented to the emergency room with complaints of lightheadedness.Upon interrogation oversensing of the minute ventilation signal was seen on the right ventricular (rv) channel.The oversensing led to pacing inhibition with asystole between five to eight seconds.Subsequently the rate response trend feature was programmed off in the cardiac resynchronization therapy pacemaker (crt-p).The crt-p and another manufacturer's rv lead remain in service and no additional adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that another manufacturer's right ventricular (rv) lead was surgically abandoned due to the high out of range pacing impedance measurements and oversensing of noise that led to pacing inhibition with asystole greater than two seconds.A new rv lead was successfully implanted.The cardiac resynchronization therapy pacemaker (crt-p) remains in service and 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: 7983926
• MDR Text Key: 124298308
• Report Number: 2124215-2018-18281
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: (01)00802526559389(17)20170112
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2017
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 100573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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
• Treatment: 4542; H120; MISMATCH; U125
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 81 YR