MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Event Description

During follow up, approximately two weeks following implant, the patient reported the device migrated out of the implant site while in the shower.The physician believes the patient manipulated the device out of its implanted position and that there may have been an associated infection, but this is not confirmed.Additional information has been requested and not yet received.

Manufacturer Narrative

Visual inspection on device did not find any anomaly that could contribute to the migration problem reported in the field.Analysis performed indicated that it exhibited normal device characteristics.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7554372
• MDR Text Key: 109572124
• Report Number: 2017865-2018-07972
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000041118
• Other Device ID Number: 05415067027320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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; Required Intervention