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

Model Number 1010

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

This device is still implanted at this time.No further information concerning this report is currently available.This investigation will be updated should further information be provided.

Event Description

It was reported that this device displayed high shock lead impedance code and the device has been deactivated.The patient has not been cooperative with regular follow-ups and they are now considered unprotected.The patient has not been seen at the clinic at this time.No adverse patient effects were reported.

Manufacturer Narrative

This report was filed to provide additional information regarding the explant of the deactivated system.The system remains within the explanting facility at this time.

Event Description

This supplemental report is being filled to include additional information regarding the explant of the deactivated system and the replacement with a new system.No additional adverse events 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
• MDR Report Key: 9209047
• MDR Text Key: 162869943
• Report Number: 2124215-2019-20945
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• 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
• 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: 08/27/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A015487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR