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

Model Number U125

Device Problem Defective Device (2588)

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory this device was thoroughly inspected and analyzed.There was no telemetry with the device.Visual examination of the device header and case noted upon opening of the can, the battery was bulging.Additionally, it was noted there was a tube tear in the cathode tab insulator which subsequently lead to a short between the cathode tab and the battery can.The investigation found that the battery shorting associated with the torn tube insulation was likely caused by sharp notch corners on the tab portion of the cathode collector.

Event Description

This device was originally returned with no allegations against the device.Upon receipt at our post market quality assurance laboratory this device was thoroughly inspected and analyzed.There was no telemetry with the device.Visual examination of the device header and case noted upon opening of the can, the battery was bulging.Additionally, it was noted there was a tube tear in the cathode tab insulator which subsequently lead to a short between the cathode tab and the battery can.The investigation found that the battery shorting associated with the torn tube insulation was likely caused by sharp notch corners on the tab portion of the cathode collector.The device was successfully explanted and replaced.No adverse patient effects were reported.

• 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
• 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: 12642948
• MDR Text Key: 276911307
• Report Number: 2124215-2021-27233
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• Combination Product (y/n): N
• 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
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2017
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 100630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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
• Patient Age: 83 YR