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 Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The icd was explanted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Patient code 3191 captures the reportable event of surgery and the additional intervention performed by the use of intravenous antibiotics.Upon receipt at our post market quality assurance laboratory product investigation indicates that the that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product was not able to provide relevant information for infection-related allegations.Additional information is pertinent as this provides significant impact that changed the overall understanding of the event.Additional information does not impact the current reporting decision.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The icd 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
• MDR Report Key: 11040274
• Report Number: 2124215-2020-26794
• Device Sequence Number: 1265616
• Product Code: LWP
• UDI-Device Identifier: 00802526480706
• UDI-Public: 00802526480706
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 11/06/2015
• Device Model Number: E053
• Device Catalogue Number: E053
• Device Lot Number: 101272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR