MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	E053
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product has been received for analysis.This report would be updated should further information be provided from the analysis.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited premature battery depletion (pbd) behavior.The battery appeared to be depleting more quickly than expected.Device replacement was recommended.Eventually, this device was surgically explanted, replaced and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Patient code 3191 captures the reportable event of surgery.The product has been received for analysis.This report would be updated should further information be provided from the analysis.The returned implantable cardioverter defibrillator was analyzed.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited premature battery depletion (pbd) behavior.The battery appeared to be depleting more quickly than expected.Device replacement was recommended.Eventually, this device was surgically explanted, replaced and returned for analysis.No additional adverse patient effects were reported.

• Brand Name: PUNCTUA ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11104416
• Report Number: 2124215-2020-25453
• Device Sequence Number: 3950538
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/15/2015
• Device Model Number: E053
• Device Catalogue Number: E053
• Device Lot Number: 101104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 01/02/2021
• Supplement Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 32 YR