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

Model Number 1010

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Arrhythmia (1721)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) presented to the emergency room due to a tachyarrhythmic storm.The s-icd was interrogated, and it was observed that the device recorded a code ps indicative that the device encountered a reset during a charge or shock.A request was made to have data from this device analyzed.Device replacement was recommended.This device was explanted and was returned for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, high powered visual inspection of the lead barrel and header of the device noted no irregularities.Analysis of the device memory revealed the device had a power supply error on 12-jul-2019.The power supply error occurs after the device encounters a reset during a charge or shock.It appears that the device operated normally after this error.The device was then subjected to and passed a series of automated testing which confirms proper operation of pacing, sensing and shocking functions of the device as well as lead impedance and telemetry testing.The device case was then reviewed and high-power visual inspections was performed.No obvious irregularities were noted.The field allegation was confirmed however the exact cause of the power supply reset could not be determined.This report is being filed to correct the manufacturer information in sections d3 and g1.

• 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: 9209049
• MDR Text Key: 162856706
• Report Number: 2124215-2019-17358
• 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: 01/25/2020

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: 05/22/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A014187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention