MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D314TRG

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 06/28/2014

Event Type  Death  

Event Description

It was reported by the patient¿s ex-spouse that the patient is deceased.Per the family member the cause of death per the death certificate is sudden cardiac death.It was further reported by the family that ¿per the funeral home and per the hospital they said the device malfunctioned, it did not go off.They said it didn¿t function at all, it failed to kick in¿.The patient was noted to have been in and out of the hospital for the last four months due to heart and kidney issues.The patient had been on dialysis earlier that day and was returned to the nursing home.The patient is reported to have been found at the hospital in cardiopulmonary arrest.Emergency services were notified and resuscitation was attempted.The patient is reported to have been taken to the hospital where the patient died.Additional information obtained from the cardiovascular clinic reported that the patient had been seen one week prior to the date of death for ¿incessant¿ ventricular tachycardia (vt) and the device system was functioning appropriately at that time.The clinician reviewed the hospital records and reported there was no information in the emergency record noting or indicating a device malfunction.The patient was noted to have been in cardiopulmonary arrest and rhythm was asystolic upon arrival to the hospital.No post mortem interrogation is reported to have been performed.The clinician further reported that the patient¿s hospital record noted critical potassium level of 1.9.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant medical products: 6945-65; lead, implanted: (b)(6) 2001; 5076-45; lead, implanted: (b)(6) 2001.

• Brand Name: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3995739
• MDR Text Key: 21239834
• Report Number: 3004209178-2014-14992
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2013
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Date Device Manufactured: 07/11/2012
• 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
• Treatment: 4194-88 LEAD
• Patient Outcome(s): Death
• Patient Age: 00061 YR