MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number	V273
Medical Device Problem Codes	Failure to Capture (1081); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was found to be in safety mode.Device replacement was recommended.Subsequently, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The patient details and model and serial number of the device were added.
Event or Problem Description
It was reported that this pacemaker was found to be in safety mode.Device replacement was recommended.Subsequently, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The patient details and model and serial number of the device were added.
Event or Problem Description
It was reported that this pacemaker was found to be in safety mode.Loss of capture on the right ventricular (rv) lead was observed.An x-ray was performed and no dislodged or fracture was confirmed.Device replacement was recommended.Subsequently, a revision procedure was performed and the pacemaker was explanted, while the rv lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: INTUA
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel MN ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19355917
• Report Number: 2124215-2024-30670
• Device Sequence Number: 12347699
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/22/2017
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 118342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 06/07/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 05/29/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male