MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U125

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited pacemaker mediated tachycardia (pmt) episodes.Technical services (ts) discussed the episodes and noted they looked like atrial tachycardia with upper rate behavior.Ts also discussed medical management of the higher rate.Additionally, the minute ventilation (mv) feature was disabled during an ablation procedure.During the procedure, right atrial (ra) impedances were greater than 3000 ohms, triggering a lead safety switch (lss) and subsequent signal artifact monitoring episodes.No adverse patient effects were reported.The device remains in service.Additional information has been requested from the field.If additional information is received, this report will be updated.

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.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited pacemaker mediated tachycardia (pmt) episodes.Technical services (ts) discussed the episodes and noted they looked like atrial tachycardia with upper rate behavior.Ts also discussed medical management of the higher rate.Additionally, the minute ventilation (mv) feature was disabled during an ablation procedure.During the procedure, right atrial (ra) impedances were greater than 3000 ohms, triggering a lead safety switch (lss) and subsequent signal artifact monitoring episodes.No adverse patient effects were reported.The device remains in service.Additional information has been requested from the field.If additional information is received, this report will be updated.

• Brand Name: VALITUDE CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13138809
• MDR Text Key: 283833358
• Report Number: 2124215-2021-38404
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/04/2019
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 707759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female