MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA CRT-D; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	N051
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609); Data Problem (3196)
Health Effect - Clinical Codes	Arrhythmia (1721); Tachycardia (2095); Electric Shock (2554)
Date of Event	01/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator experienced supraventricular tachycardia (svt).The device provided inappropriate anti-tachycardia pacing (atp) and inappropriate shocks.This happened on three separate occasions.Technical services (ts) noted that in some of the episodes the atp looked like it was pro-arrhythmic, putting the patient into ventricular tachycardia.Ts discussed programming options with the health care professional.The device remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator experienced supraventricular tachycardia (svt).The device provided inappropriate anti-tachycardia pacing (atp) and inappropriate shocks.This happened on three separate occasions.Technical services (ts) noted that in some of the episodes the atp looked like it was pro-arrhythmic, putting the patient into ventricular tachycardia.Ts discussed programming options with the health care professional.The device remains in service.No additional adverse patient effects were reported.Additional information was received that the patient experienced two additional ventricular tachycardia events with atp in which there were no electrograms (egm) available.Ts reviewed and discussed this was due to storage limitations.A magnet was applied which freed up some egm space which ts discussed will allow future episodes to store.No adverse patient effects were reported.
Additional Manufacturer Narrative
The device has been returned for analysis.A supplemental report will be filed at the time of completion.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator experienced supraventricular tachycardia (svt).The device provided inappropriate anti-tachycardia pacing (atp) and inappropriate shocks.This happened on three separate occasions.Technical services (ts) noted that in some of the episodes the atp looked like it was pro-arrhythmic, putting the patient into ventricular tachycardia.Ts discussed programming options with the health care professional.The device remains in service.No additional adverse patient effects were reported.Additional information was received that the patient experienced two additional ventricular tachycardia events with atp in which there were no electrograms (egm) available.Ts reviewed and discussed this was due to storage limitations.A magnet was applied which freed up some egm space which ts discussed will allow future episodes to store.No adverse patient effects were reported.Additional information was received that the device was explanted and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator experienced supraventricular tachycardia (svt).The device provided inappropriate anti-tachycardia pacing (atp) and inappropriate shocks.This happened on three separate occasions.Technical services (ts) noted that in some of the episodes the atp looked like it was pro-arrhythmic, putting the patient into ventricular tachycardia.Ts discussed programming options with the health care professional.The device remains in service.No additional adverse patient effects were reported.Additional information was received that the patient experienced two additional ventricular tachycardia events with atp in which there were no electrograms (egm) available.Ts reviewed and discussed this was due to storage limitations.A magnet was applied which freed up some egm space which ts discussed will allow future episodes to store.No adverse patient effects were reported.Additional information was received that the device was explanted and returned for analysis.No additional adverse patient effects were reported.

• Brand Name: PUNCTUA CRT-D
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 11660669
• Report Number: 2124215-2021-04672
• Device Sequence Number: 19686901
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/08/2023

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: 03/26/2013
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 100668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 01/03/2022; 09/15/2022; 05/04/2023
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 03/07/2022; 09/19/2022; 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2011
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male