MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE DEVICE

Model Number	1010
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.As received for analysis, the setscrews operated normally in both directions, and high power visual inspection of the setscrews noted no irregularities.The hex slot was undamaged, and no foreign material was noted within the hex cavity.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Most likely the setscrew was stuck up inside the capture washer; the typical reason for this being the use of an incorrect wrench.
Event or Problem Description
It was reported that during an explant procedure for normal battery depletion, the setscrews on this subcutaneous implantable cardioverter defibrillator (s-icd) were stuck.The physician was able to free the setscrews after hearing a ratcheting sound.This s-icd was successfully explanted, replaced, and returned for analysis.No adverse patient effects were reported.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16404225
• Report Number: 2124215-2023-07654
• Device Sequence Number: 12127903
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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: 09/19/2014
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A006318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/20/2023
• 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: 58 YR
• Patient Sex: Male