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

Model Number	E051
Medical Device Problem Codes	Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591); Noise, Audible (3273)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pulse generator emitted beeping tones and an alert for voltage too low for projected remaining capacity.A replacement surgery will be scheduled.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pulse generator emitted beeping tones and an alert for voltage too low for projected remaining capacity.This device was explanted at a surgical intervention.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Patient code 3191 captures the reportable event stating that the patient was sent to surgery.The returned implantable pulse generator was analyzed and a review of the device memory confirmed 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.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to this anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was not included in the advisory population.

• Brand Name: PUNCTUA ICD
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9571568
• Report Number: 2124215-2019-27592
• Device Sequence Number: 2132914
• Product Code: LWP
• UDI-Device Identifier: 00802526480683
• UDI-Public: 00802526480683
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 11/08/2014
• Device Model Number: E051
• Device Catalogue Number: E051
• Device Lot Number: 100683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR