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

Model Number 1458Q/75

Device Problems Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Ischemia (1942); Ventricular Tachycardia (2132)

Event Date 10/17/2017

Event Type  Death  

Event Description

It was reported that the patient passed away.The cause of death is cardiac, ischemic and sudden.The patient had ventricular tachycardia at the time of the death.There is no known allegation from a health professional that suggests the death was related to the device.No further information is available at this time.

Event Description

New information received indicates that the patient presented to the hospital for abdominal cramping.Cardiology consultant also suggested possible infarct.The patient experienced multifocal ventricular tachycardia with altered level of consciousness.No hv output and lv output was noted.Cpr was initiated, but the patient remained in refractory vt despite aggressive efforts.The patient was pronounced dead.Significant condition contributing to death is gastrointestinal bleeding.

• Brand Name: QUARTET
• 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: 7022987
• MDR Text Key: 91741516
• Report Number: 2938836-2017-33828
• 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: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 1458Q/75
• Device Lot Number: 3822214
• Other Device ID Number: 05414734503334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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