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

Model Number	E053
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient is not followed remotely and a normal follow up visit 7 months ago identified there was 9 months remaining longevity.However, a few weeks later the device declared elective replacement indicator (eri).A full evaluation report from the date of the interrogation was not available and disk analysis was not performed.A boston scientific technical services consultant discussed eri could have been triggered due to charge time.The previous long evaluation session coupled with a routine capacitor reformation right away that made the average power consumption very high for that week could have declared explant to maintain the 90 days replacement interval.The device was subsequently explanted and is expected to be returned for evaluation.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This investigation will be updated should further information be provided.

• 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: 20202662
• Report Number: 2124215-2024-57085
• Device Sequence Number: 6815211
• Product Code: LWP
• UDI-Device Identifier: 00802526480706
• UDI-Public: 00802526480706
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/05/2012
• Device Model Number: E053
• Device Catalogue Number: E053
• Device Lot Number: 100132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/12/2024
• Date Device Manufactured: 07/18/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male