MAUDE Adverse Event Report: EXTERNAL MANUFACTURER S-ICD SYSTEM; IMPLANTABLE LEAD

Model Number 3401

Device Problems Premature Discharge of Battery (1057); High impedance (1291); Low impedance (2285)

Patient Problems Syncope (1610); Sepsis (2067); Ventricular Tachycardia (2132); Loss Of Pulse (2562); Patient Problem/Medical Problem (2688)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this patient is in the hospital with sepsis and is on dialysis.The patient experienced arrest due to a ventricular tachycardia (vt) episode which was converted with one shock.A review of the device data identified the shock impedance was 14 ohms.System evaluation was being performed and during manual set-up, the impedance measurement was noted to be greater than 400 ohms.Sensing measurements were confirmed to be appropriate.The caller stated this patient has a lot of equipment in use such as a hypothermia blanket and a dialysis machine.The patient developed pulseless electrical activity (pea) after the shock converted the arrhythmia and is intubated and on a ventilator.Review of the device data was evaluated by a boston scientific engineer who confirmed the clinical observations of a low high energy shock impedance followed by an open sub-threshold shock impedance.Additionally, the power consumption has been increasing steadily which is consistent with degradation of an internal hardware component.The system remains implanted.No additional adverse patient effects were reported.

• Brand Name: S-ICD SYSTEM
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• Manufacturer (Section G): EXTERNAL MANUFACTURER
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 8028861
• MDR Text Key: 125820583
• Report Number: 2124215-2018-19290
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: 00802526575600
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S043
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2018
• Device Model Number: 3401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/07/2018
• 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
• Patient Sequence Number: 1
• Treatment: 3401; A209
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 60 YR