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 No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Records indicate this device remains in service.This investigation will be updated should further information be provided.

Event Description

It was reported this subcutaneous implantable cardioverter defibrillator (s-icd) had reached elective replacement indicator (eri).Additionally, a long charge code was also observed.Boston scientific technical services (ts) discussed this device was included in the november 2018 sq-rx model 1010 pg shortened replacement interval advisory population.Device replacement was recommended.No adverse patient effects were reported.

• 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
• Manufacturer (Section G): CAMERON HEALTH; 4100 hamline ave n; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9667925
• MDR Text Key: 178351293
• Report Number: 2124215-2019-29018
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A011147
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0474-2019
• Patient Sequence Number: 1
• Patient Age: 55 YR