MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2211-36Q

Device Problem Premature Discharge of Battery (1057)

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

Event Date 12/06/2017

Event Type  Injury  

Event Description

It was reported that an asymptomatic patient presented in-clinic for routine follow-up.Upon interrogation, the implantable cardioverter defibrillator displayed low battery voltage; premature battery depletion was suspected.The patient did not experience high voltage therapy.The device was explanted and replaced.The patient was stable post procedure.

Manufacturer Narrative

Longevity estimation was performed and found to be within expected longevity performance.The device was tested on the bench and no anomalies were found.

Event Description

Upon further investigation it was noted the programmer overestimated the battery longevity.The root cause for the inconsistent remaining longevity estimate near eri indicated by the programmer was not identified.

• Brand Name: CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 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: 7149743
• MDR Text Key: 95895529
• Report Number: 2017865-2017-36697
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

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: 08/31/2011
• Device Model Number: CD2211-36Q
• Device Lot Number: 3074825
• Other Device ID Number: 05414734503709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2010
• 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): Required Intervention
• Patient Age: 60 YR