MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CURRENT ACCEL DR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2215-36

Device Problem Connection Problem (2900)

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

Event Date 09/22/2017

Event Type  malfunction  

Event Description

During replacement surgery, the right ventricular lead could not be removed from the header of the device even after the set screw was removed.The lead was capped and replaced and the device was explanted and replaced to resolve the event.The patient's condition was stable following the procedure.Related manufacturer reference number: 2938836-2017-33515.

Manufacturer Narrative

The reported event of the right ventricular lead could not be removed was not confirmed in the lab.Interrogation of the device revealed the device was at the elective replacement indicator when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.The rf antenna and the header was damaged with parts missing.A set screw was also missing.Leads were placed and did not get stuck.The cause of the field event remains undetermined.

• Brand Name: CURRENT ACCEL DR, 36J
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7003050
• MDR Text Key: 91298683
• Report Number: 2938836-2017-33513
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P910023
• 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: 06/29/2018

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: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: CD2215-36
• Device Lot Number: 2924318
• Other Device ID Number: 05414734502641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2009
• 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