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

Model Number D354TRM

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2014

Event Type  Injury  

Event Description

It was reported that a microdislodgement occurred.During the revision procedure the physician could not properly fix the lead so a new lead was implanted.It was also reported that during the revision procedure the physician lost the device right ventricular (rv) lead set screw.A new device was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the united states; however, it is same/similar to a device marketed in the u.S.This event occurred outside the us and patient information is not generally available due to confidentiality concerns.Products: 5866-40m, lead adaptor.(b)(4).

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis revealed no anomalies were found.The returned device indicated a loose/detached set screw.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA XT 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 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: 4315644
• MDR Text Key: 5210296
• Report Number: 9614453-2014-03006
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2014
• Device Model Number: D354TRM
• Device Catalogue Number: D354TRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2013
• 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: 6947M62, LEAD
• Patient Outcome(s): Required Intervention