MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA ICD; IMPLANTABLE PACEMAKER

Model Number	E051
Medical Device Problem Codes	Premature Discharge of Battery (1057); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) triggered code 1003 indicative of voltage too low for projected remaining capacity.Save to disk data was sent to engineering for review.No adverse patient effects were reported.
Additional Manufacturer Narrative
This second supplemental was created to add the device analysis and add.This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Review of the device memory indicated that a low voltage alert, code 1003, was recorded.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's battery.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.H.Device manufacturers only 3.Device evaluated by manufacturer? 10.Device manufacturers narrative.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) triggered code 1003 indicative of voltage too low for projected remaining capacity.Save to disk data was sent to engineering for review.Device was explanted and returned to boston scientific.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Supplemental report is created to correct the following: b.Adverse event or product problem.1.Type of report.2.Outcome attribute to adverse event.5.Describe event or problem.H.Device manufacturers only.1.Type of reportable event.3.Device evaluated by manufacturer?.6.Adverse event problem in health effect - impact code.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) triggered code 1003 indicative of voltage too low for projected remaining capacity.Save to disk data was sent to engineering for review.Device was explanted and returned to boston scientific.No additional adverse patient effects were reported.

• Brand Name: PUNCTUA ICD
• Common Device Name: IMPLANTABLE PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12250559
• Report Number: 2124215-2021-22015
• Device Sequence Number: 14618701
• Product Code: LWP
• UDI-Device Identifier: 00802526480683
• UDI-Public: 00802526480683
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2021

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: 09/02/2015
• Device Model Number: E051
• Device Catalogue Number: E051
• Device Lot Number: 101054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021; 09/01/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/05/2021; 10/05/2021
• 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: 68 YR