MAUDE Adverse Event Report: CAMERON HEALTH SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 1010

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

The device was received and is undergoing analysis.This report will be updated when analysis is complete.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received appropriate shocks for a ventricular tachycardia (vt)/ventricular fibrillation (vf).The first shock was successful but the arrhythmia recurred and the next shock did not convert.The field representative reported the patient received a third shock but no episode was stored.The patient was successfully resuscitated but remains in poor condition due to comorbidities following a kidney transplant.The patient is also awaiting a heart transplant.Interrogation of the device revealed a power supply (ps) and a lost template (lt) error code.Technical services reviewed the device data and confirmed that due to the power supply errors the device experienced resets, resulting in the last episode not getting stored.Device and electrode replacement was recommended, as the device resets would likely delay any shock therapy.X-rays were recommended to verify the position of the electrode; since the ps errors happened while shocking, it was suspected that contact between the electrode and the device had occurred and the electrode insulation was possibly compromised.The field representative later reported that the physician understood the system required replacement but no procedure would be performed until the patient's condition was improved.Approximately six weeks later, the s-icd system was explanted and replaced.The patient was in good condition.The explanted products were returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received appropriate shocks for a ventricular tachycardia (vt)/ventricular fibrillation (vf).The first shock was successful but the arrhythmia recurred and the next shock did not convert.The field representative reported the patient received a third shock but no episode was stored.The patient was successfully resuscitated but remains in poor condition due to comorbidities following a kidney transplant.The patient is also awaiting a heart transplant.Interrogation of the device revealed a power supply (ps) and a lost template (lt) error code.Technical services reviewed the device data and confirmed that due to the power supply errors the device experienced resets, resulting in the last episode not getting stored.Device and electrode replacement was recommended, as the device resets would likely delay any shock therapy.X-rays were recommended to verify the position of the electrode; since the ps errors happened while shocking, it was suspected that contact between the electrode and the device had occurred and the electrode insulation was possibly compromised.The field representative later reported that the physician understood the system required replacement but no procedure would be performed until the patient's condition was improved.Approximately six weeks later, the s-icd system was explanted and replaced.The patient was in good condition.The explanted products were returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

The device was received and is undergoing analysis.This report will be updated when analysis is complete.Patient code 3191 captures the reportable event of surgery.Upon receipt at our post market quality assurance laboratory, the device was thoroughly evaluated and analyzed.Visual inspection noted some tool marks on the device case.The seal plug was intact and the setscrew moved freely.The device was interrogated with a monitoring voltage of 8.774v and the remaining battery life to elective replacement indicator (eri) was 12%.The power supply (ps) and lost template (lt) error messages and the memory reset observed clinically were caused by a temporary interruption of power to the circuitry.Review of the device memory found on november 7, 2019 (the date of the event) the device became stuck in a loop for nine cycles, then the device began operating normally, where the device sensed arrhythmias and delivered therapy.In the laboratory, the device passed electrical testing.The device case was then removed for inspection of the internal components.Internal visual inspection noted a crack on the solder connection of the inline fuse on the battery assembly.Laboratory analysis concluded that this cracked solder caused the power interruption.Of note, this model device is no longer manufactured.

• Brand Name: SQ-RX PULSE GENERATOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): CAMERON HEALTH; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9630289
• MDR Text Key: 176387780
• Report Number: 2124215-2019-28556
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A017151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 01/25/2020
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 05/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention