MAUDE Adverse Event Report: IPG MFG SWITZERLAND CONSULTA CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D224TRK

Device Problem Nonstandard Device (1420)

Patient Problems Fatigue (1849); Weakness (2145); Tingling (2171)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

It was reported by the patient that the patient has been hearing intermittent tones from the device for about a week and presented to the emergency room (er).The patient has also been experiencing fatigue, weakness, difficulty breathing and tingling in the arms, but also stated the issues started after beginning to work out at the gym.Follow-up with the device clinic was attempted however the patient had not contacted the physician and no additional information could be obtained.The device remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.This device was included in a field action.Based on the information received and without the return of the product, it could not be determined if this device performed as described in the field action.Product: 4054 lead 2009 (b)(6).(b)(4).

• Brand Name: CONSULTA CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 4162656
• MDR Text Key: 21526707
• Report Number: 9614453-2014-02511
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2011
• Device Model Number: D224TRK
• Device Catalogue Number: D224TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 10/10/2014
• Date Device Manufactured: 01/16/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0111-2011
• Patient Sequence Number: 1
• Treatment: 6947-65 LEAD, 5071-53 LEAD
• Patient Age: 00054 YR