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 Problems Intermittent Capture (1080); Failure to Capture (1081); High Capture Threshold (3266); Unstable Capture Threshold (3269)

Patient Problems Syncope (1610); Bruise/Contusion (1754); Chest Pain (1776); Contusion (1787); Fall (1848); Head Injury (1879); Dizziness (2194)

Event Date 09/13/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant products: 6947-58, lead, 4396-88, lead, implanted: (b)(6) 2012.(b)(4).Evaluation summary: upon analysis, no anomalies were found.Performance data collected from the device was received and analyzed, and no anomalies were found.

Event Description

It was reported that the patient experienced multiple syncopal episodes which resulted in a fall and they hit their head.They sustained a black eye and a lip contusion due to the syncope and have had frequent dizziness with muscle aches and pain in the left chest area.The implantable cardioverter defibrillator (icd) exhibited demonstrable loss of capture in the right ventricular (rv) and left ventricular (lv) leads at the same time.There was fluctuating and high rv thresholds.Initially, capture management was turned off in the rv and lv and the patient was attached to external pacing pads with a crash cart.The icd was later explanted and replaced.No further patient complications have been reported as a result of this event.

• 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 HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5280185
• MDR Text Key: 33166126
• Report Number: 3004209178-2015-24262
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2014
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2012
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00072 YR