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

Model Number	E051
Medical Device Problem Codes	Premature Discharge of Battery (1057); Telemetry Discrepancy (1629); Battery Problem (2885); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this patients implantable cardioverter defibrillator (icd) could not be interrogated.Troubleshooting steps were performed that were not successful which included using a magnet, switching programmers, moving the programmer from shoulder to chest over this icd, power cycling the programmer and moving to a different room with the programmer.A request was made to have data from this device analyzed.Data analysis confirmed that at the previous interrogation, there were signs of instability in the battery voltage which is consistent with internal shorts in the battery.Ultimately, this icd was explanted and replaced with a different device, which remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed no anomalies.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.A normal current drain was observed within the circuitry.Collectively, the pattern of irregular daily battery voltage measurements in conjunction with normal power levels and device hybrid current draw is consistent with behavior of devices where a latent current leakage path has occurred within the battery itself, resulting in a partial depletion of the battery.This behavior is caused by a latent electrical leakage path that develops over time between the anode and cathode within the device battery.In certain circumstances, lithium metal ions can re-plate to form clusters that may result in an internal current leakage.A design enhancement was implemented in 2013 to enlarge the physical barrier between the electrode layers to prevent current leakage in the area of the battery that is most often affected by this behavior.
Event or Problem Description
It was reported that this patients implantable cardioverter defibrillator (icd) could not be interrogated.Troubleshooting steps were performed that were not successful which included using a magnet, switching programmers, moving the programmer from shoulder to chest over this icd, power cycling the programmer and moving to a different room with the programmer.A request was made to have data from this device analyzed.Data analysis confirmed that at the previous interrogation, there were signs of instability in the battery voltage which is consistent with internal shorts in the battery.Ultimately, this icd was explanted and replaced with a different device, which remains in service.No additional adverse patient effects were reported.

• 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: 16741879
• Report Number: 2124215-2023-17610
• Device Sequence Number: 20177881
• Product Code: LWP
• UDI-Device Identifier: 00802526480683
• UDI-Public: 00802526480683
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 03/24/2016
• Device Model Number: E051
• Device Catalogue Number: E051
• Device Lot Number: 101314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male