MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE

Model Number 1056T/75

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

Patient Problems Congestive Heart Failure (1783); Death (1802); High Blood Pressure/ Hypertension (1908)

Event Date 09/19/2017

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is unknown.No further information is available at this time.

Event Description

New information notes that the cause of death was sudden.

Event Description

New information notes that the patient had a history of dicm, chf, cad, hyperlipidemia, hypertension and diabetes ii.On (b)(6) 2017 patient presented to the clinic for respiratory distress and was admitted in the hospital for a stroke.While in the ed patient was found to have an elevated troponin, chronic systolic and diastolic heart failure.Shortness of breath got better and patient was discharged.Patient returned to the hospital on (b)(6) 2017 for subacute rehabilitation after a recent prolong stay at another facility.On the morning following admission the patient was found unresponsive without any pulse or respirations.A code blue was called and the patient was evaluated by the physician.The patient was found to be very cool to touch with mottled extremities and pupils fixed and dilated.There was not cardiac activity or spontaneous respirations.The patient was pronounced death.It was noted that the patient¿s death was not device or study related.

• Brand Name: QUICKSITE LV
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7585457
• MDR Text Key: 110569513
• Report Number: 2938836-2018-07471
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2009
• Device Model Number: 1056T/75
• Device Lot Number: 0002120920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2006
• 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
• Patient Outcome(s): Death
• Patient Age: 85 YR