MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	1010
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that a premature battery depletion (bd) alert was observed for this subcutaneous implantable cardioverter defibrillator (s-icd) that was scheduled for replacement, as end of life (eol) had been reached approximately 3 years prior.Technical services (ts) recommended explant as soon as possible.This s-icd remains in service at this time.No adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was analyzed and the reported event was confirmed.Based on a review of all available information, the cause of the reported event could not be determined because the battery cells were too depleted to evaluate, and no high current was found.
Event or Problem Description
It was reported that a premature battery depletion (bd) alert was observed for this subcutaneous implantable cardioverter defibrillator (s-icd) that was scheduled for replacement, as end of life (eol) had been reached approximately 3 years prior.Technical services (ts) recommended explant as soon as possible.This s-icd remains in service at this time.No adverse patient effects were reported.Additional information was received that this s-icd was explanted due to normal battery depletion.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17540932
• Report Number: 2124215-2023-43286
• Device Sequence Number: 12381839
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A014402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female