MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number U128

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Death (1802); Electro-Mechanical Dissociation (1826); Unspecified Infection (1930); Sepsis (2067)

Event Date 01/25/2017

Event Type  Death  

Manufacturer Narrative

The local representative was notified on february 13, 2017 by a health care professional (hcp) that this patient had died on (b)(6) 2017.According to the hcp, the patient's latitude monitoring system was reviewed and no issues were identified.A family member mentioned that throughout the night of (b)(6), the patient's blood sugars were checked because of low measurements.Because the patient's blood sugars continued to be low, glucagon was given.Blood sugars were not checked after glucagon was given.The family member contacted the paramedics.The paramedics informed the family member that from the ekg, there was pacing output but the patient had no pulse.The patient's family did not have an autopsy done.The device was received at boston scientific's return product department and is currently undergoing laboratory testing.

Event Description

Boston scientific received information from the local representative that this patient had been scheduled for a pocket revision on (b)(6) 2017 due to pocket erosion.The patient was presented to the electrophysiology (ep) laboratory.Due to scar tissue and oozing of the pocket, the procedure required an extended period of time to complete.There were no patient adverse event and the system remained in-service.On (b)(6) 2017, the patient was scheduled for a device and lead extraction due to infection/sepsis and erosion.This surgical procedure was scheduled in the hospital's operating room.The local representative had contacted boston scientific's technical services on the day of system explant to report that the patient was pacemaker dependent and the physician planned to place a permanent pacing lead for bradycardia on the opposite side.Additionally, the physician was planning to use the chronic left ventricular (lv) lead for bradycardia pacing support until the system was extracted and the permanent system placed on the opposite side.Before the procedure, the local representative was informed by the physician that the patient was seen by a hospitalist between the revision and explant procedure.The hospitalist may have disrupted the incision possibly leading to the erosion and infection.The chronic system was explanted and a replacement system was implanted on the patient's opposite side.The physician did have difficulty removing the fineline lead.The lead was destroyed or came apart due to the extraction tool cutting through it.The patient spent a couple of days in the hospital without incident.The patient was discharged from the hospital on (b)(6) 2017.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.Visual and mechanical inspection of the set screws was performed.The set screws were found to move normally and completely in both clockwise and counter clockwise directions.A cut was noted in the left ventricular (lv) seal plug.The other seal plugs were intact and undamaged.Analysis of the device memory noted no irregularities.No battery faults were present and the battery status of the device was good associated with a battery voltage of 3.003 volts.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6387304
• MDR Text Key: 69358400
• Report Number: 2124215-2017-03892
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: (01)00802526559402(17)20181027
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2018
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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: 4470; 4674; 7742; L131; U128
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR