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

Model Number D284TRK

Device Problems Nonstandard Device (1420); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 05/06/2011

Event Type  Injury  

Event Description

It was reported that product performance data was reviewed and classified as inappropriate treatment/shock.The device remains in use.The patient was enrolled in the (b)(4) study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This report is based solely on reviewed clinical data from the device.If additional relevant information is received, a supplemental report will be submitted.(b)(4).This device was included in the 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.

• Brand Name: MAXIMO II 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: 3768191
• MDR Text Key: 4356497
• Report Number: 9614453-2014-00972
• 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: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/25/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2011
• Device Model Number: D284TRK
• Device Catalogue Number: D284TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2011
• Date Device Manufactured: 05/07/2010
• 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-0112-2011
• Patient Sequence Number: 1
• Treatment: 694775 IMPLANTABLE TACHY LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 00065 YR