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

Model Number V173

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Telemetry Discrepancy (1629); Inappropriate or Unexpected Reset (2959)

Patient Problems Device Overstimulation of Tissue (1991); Anxiety (2328); Discomfort (2330)

Event Date 08/21/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room (er) due to a jumpy feeling in their chest, and attempts to interrogate this cardiac resynchronization therapy pacemaker (crt-p) were unsuccessful.Technical services (ts) noted that this crt-p is included in the high impedance in ingenio el pacemakers and crt-ps advisory population which can result in devices going into safety mode.Ts noted that the jumpiness the patient was feeling in their chest was likely a result of the unipolar left ventricular (lv) lead pacing while in safety mode.In addition, pacing inhibition related to myopotential oversensing was identified.This crt-p was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room (er) due to a jumpy feeling in their chest, and attempts to interrogate this cardiac resynchronization therapy pacemaker (crt-p) were unsuccessful.Technical services (ts) noted that this crt-p is included in the high impedance in ingenio el pacemakers and crt-ps advisory population which can result in devices going into safety mode.Ts noted that the jumpiness the patient was feeling in their chest was likely a result of the unipolar left ventricular (lv) lead pacing while in safety mode.In addition, pacing inhibition related to myopotential oversensing was identified.This crt-p was explanted and replaced.No additional adverse patient effects were reported.Additional information received reported that the patient had experienced discomfort and anxiety while hospitalized prior to device replacement due to the cardiac resynchronization therapy pacemaker (crt-p) that was in safety mode.The crt-p was successfully explanted and replaced with no complications, and it was reported that the patient fully recovered.No additional adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INVIVE
• 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: 15287736
• MDR Text Key: 298558565
• Report Number: 2124215-2022-32414
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 106350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male