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

Model Number	E053
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of system revision due to infection.No additional adverse patient effects were reported.The pacemaker was explanted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the device was not confirmed.The device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental report is being filed to correct the d9: device avail for eval; d9: device return date; g2: report source; h2: follow-up type; and h3: device eval by manufacturer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of system revision due to infection.No additional adverse patient effects were reported.The pacemaker was explanted.

• Brand Name: PUNCTUA ICD
• 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: 18390529
• Report Number: 2124215-2023-73526
• Device Sequence Number: 11767359
• Product Code: LWP
• UDI-Device Identifier: 00802526480706
• UDI-Public: 00802526480706
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S235
• 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: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/10/2015
• Device Model Number: E053
• Device Catalogue Number: E053
• Device Lot Number: 101289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/25/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2013
• 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: 80 YR
• Patient Sex: Male