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

Model Number S603

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

Patient Problems Death (1802); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 06/07/2018

Event Type  Death  

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 field clinical representative (fcr) contacted boston scientific's technical services on (b)(6) 2018.The fcr called to report that this patient was presented back to the electrophysiology (ep) laboratory on (b)(6) 2018 for pacemaker and lead system extraction due to infection/sepsis.Following the procedure, the patient was to be treated with antibiotics.The extraction of the entire system was successful and uneventful.The fcr was notified on (b)(6) 2018 that the patient had died during the early morning of (b)(6) 2018.The fcr was notified that the patient's medical history was significant for dialysis and that the patient had refused medication.The patient was hyperkalemic at 6.7 meq/litter.

• Brand Name: ALTRUA
• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7655981
• MDR Text Key: 112935137
• Report Number: 2124215-2018-11898
• Device Sequence Number: 1
• Product Code: LWP
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2012
• Device Model Number: S603
• Other Device ID Number: ALTRUA 60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2010
• 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: 4135; 4136; S603
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR