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

Model Number U125

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 07/06/2021

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker showed high out-of-range impedance measurements of over 3000 ohms on the left ventricular lead.X-rays were performed as it was suspected that this lead was not fully inserted.Technical services reviewed the x-rays but could not tell if the lead was fully inserted or not.It was recommended to just monitor the patient for now.Both the device and the lead remain 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12514732
• MDR Text Key: 272870164
• Report Number: 2124215-2021-20095
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2021
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 714234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR