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

Model Number	V272
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
This cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead triggered a lead safety switch (lss) to unipolar due to a high out-of-range pace impedance measurement of 2,012 ohms.The vector was reprogrammed successfully and the lss for the lv lead was programmed off.This crt-p and lv lead remain in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
This cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead triggered a lead safety switch (lss) to unipolar due to a high out-of-range pace impedance measurement of 2,012 ohms.The vector was reprogrammed successfully and the lss for the lv lead was programmed off.This crt-p and lv lead remain in service.No adverse patient effects were reported.Additional information received reported that the cardiac resynchronization therapy pacemaker (crt-p) was explanted and replaced due to normal battery depletion (nbd).In addition, a left ventricular (lv) adapter was placed.This left ventricular (lv) lead remains in service.It was noted that the lv pace impedance measurement with the new crt-p was 1142 ohms.No additional adverse patient effects were reported.

• Brand Name: INTUA
• Common Device Name: 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: 15486097
• Report Number: 2124215-2022-37411
• Device Sequence Number: 8133072
• Product Code: NKE
• UDI-Device Identifier: 00802526536663
• UDI-Public: 00802526536663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

1 Device was Involved in the Event

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: 06/10/2016
• Device Model Number: V272
• Device Catalogue Number: V272
• Device Lot Number: 100199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2014
• 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: 54 YR
• Patient Sex: Female