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); Noise, Audible (3273)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.The device emitted beeping tones associated to the code 1003.This device remains in service, but device replacement was recommended in less than 2 months since date of event.No adverse patient effects were reported.
Additional Manufacturer Narrative
The returned implantable cardioverter defibrillator (icd) 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 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 recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.The device emitted beeping tones associated to the code 1003.Device replacement was recommended.This device was already replaced and returned for analysis.Follow ups were increased as a result.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
• MDR Report Key: 9965790
• Report Number: 2124215-2020-07258
• Device Sequence Number: 11298461
• Product Code: LWP
• UDI-Device Identifier: 00802526480706
• UDI-Public: 00802526480706
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 02/01/2014
• Device Model Number: E053
• Device Catalogue Number: E053
• Device Lot Number: 100765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR