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

Model Number	E053
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 message indicator that the battery voltage is too low for the projected remaining capacity.The battery was suspected to be depleting more quickly than expected.Device replacement was recommended.No adverse patient effects were reported.
Additional Manufacturer Narrative
Patient code 3191 captures the reportable event of surgery.The product is not expected to be returned.If the product is returned, analysis would be performed and this report would be updated at that time.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 message indicator that the battery voltage is too low for the projected remaining capacity.The battery appeared to be depleting more quickly than expected.This device was surgically explanted and replaced, it is not expected to be returned.No additional adverse patient effects were reported.

• Brand Name: PUNCTUA ICD
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10621491
• Report Number: 2124215-2020-17099
• Device Sequence Number: 11420688
• Product Code: LWP
• UDI-Device Identifier: 00802526480706
• UDI-Public: 00802526480706
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 01/23/2016
• Device Model Number: E053
• Device Catalogue Number: E053
• Device Lot Number: 101388
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR