MAUDE Adverse Event Report: IPG MFG SWITZERLAND CONCERTO; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number C154DWKJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/10/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was redness on the implant site.The patient was revealed to have an allergy to metals.The implantable cardioverter defibrillator (icd) was removed.This event was documented during post-market surveillance of cardiac resynchronization therapy (crt) devices.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONCERTO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz ; CH
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5527033
• MDR Text Key: 41187921
• Report Number: 9614453-2016-01640
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2009

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2009
• Device Model Number: C154DWKJ
• Device Catalogue Number: C154DWKJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2009
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: 10/01/2009
• Supplement Dates FDA Received: 09/20/2017
• Date Device Manufactured: 08/06/2007
• 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: 5554-53 LEAD, 1580 COMPETITOR LEAD, C154DWKJ ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00069 YR