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

Model Number 1010

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

The device remains implanted.This investigation will be updated should further information be provided.

Event Description

It was reported that upon interrogation of this subcutaneous implantable cardioverter defibrillator (s-icd), a red warning screen was displayed on the programmer with a battery depletion (bd) error code.The remaining longevity had been 41% in (b)(6) and was now 25% in (b)(6).Technical services requested that device data be submitted for engineering evaluation.Upon review, it was confirmed the bd error had occurred on (b)(6) 2019 and the device was depleting prematurely.Device replacement was recommended, and it was discussed that the device could reach elective replacement indicator (eri) battery status in two to three weeks.However, the field representative later confirmed that while the patient did meet with the physician to discuss that the device needed to be replaced, the patient was currently considering not replacing the device.No adverse patient effects were reported.

Manufacturer Narrative

The device remains implanted.This investigation will be updated should further information be provided.The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that upon interrogation of this subcutaneous implantable cardioverter defibrillator (s-icd), a red warning screen was displayed on the programmer with a battery depletion (bd) error code.The remaining longevity had been 41% in august and was now 25% in november.Technical services requested that device data be submitted for engineering evaluation.Upon review, it was confirmed the bd error had occurred on (b)(6) 2019 and the device was depleting prematurely.Device replacement was recommended, and it was discussed that the device could reach elective replacement indicator (eri) battery status in two to three weeks.However, the field representative later confirmed that while the patient did meet with the physician to discuss that the device needed to be replaced, the patient was currently considering not replacing the device.No adverse patient effects were reported.About 26 months later, this device was received for disposal.No additional information about the patient or explant procedure was available.

Manufacturer Narrative

The device remains implanted.This investigation will be updated should further information be provided.The product has been received for analysis.This report will be updated upon completion of analysis.The returned s-icd was analyzed and a review of device memory found the device recorded a battery depletion alert on 7-nov-2019 and reached end of life (eol) battery status on 24-nov-2019.The device case was removed to facilitate inspection of the internal components.Visual examination of the interior identified no anomalies.Detailed analysis identified an internal battery short that resulted in the observed depletion.Note that the sq-rx (model 1010) s-icd is the only boston scientific device manufactured with a battery potentially susceptible to this particular issue.The sq-rx device is no longer manufactured; the current generation of s-icds contain a different battery (manufactured by boston scientific).This device was included in the november 2018 sq-rx model 1010 pg shortened replacement interval advisory population.

Event Description

It was reported that upon interrogation of this subcutaneous implantable cardioverter defibrillator (s-icd), a red warning screen was displayed on the programmer with a battery depletion (bd) error code.The remaining longevity had been 41% in august and was now 25% in november.Technical services requested that device data be submitted for engineering evaluation.Upon review, it was confirmed the bd error had occurred on (b)(6), 2019 and the device was depleting prematurely.Device replacement was recommended, and it was discussed that the device could reach elective replacement indicator (eri) battery status in two to three weeks.However, the field representative later confirmed that while the patient did meet with the physician to discuss that the device needed to be replaced, the patient was currently considering not replacing the device.No adverse patient effects were reported.About 26 months later, this device was received for disposal.No additional information about the patient or explant procedure was available.

• Brand Name: SQ-RX PULSE GENERATOR
• Type of Device: 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; cashel road; st paul MN ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9638826
• MDR Text Key: 176657435
• Report Number: 2124215-2019-28702
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A020102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 01/19/2022; 03/28/2023
• Supplement Dates FDA Received: 04/13/2022; 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0474-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention