MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT DR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	2207-36
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported field event of fast charge time was confirmed.Over current detection (ocd) was observed when reviewing the device image and session records.The algorithm detected a short in the output module and aborted the charge thus resulted in a fast charge time.The cause of the issue was determined to be due to intermittent hybrid anomaly but could not be conclusively determined.The device tested otherwise normal.
Event or Problem Description
It was reported that the patient presented in clinic for follow up.Upon device interrogation, the implantable cardioverter defibrillator exhibited a short charge time.Further investigation revealed that the device aborted therapy due to low high voltage impedance on the patient's right ventricular lead.Subsequent therapy was delivered with the device having charged for therapy delivery from the previous episode prior to therapy being aborted resulting in the short charge time.The device was explanted for reaching normal elective replacement indicator and replaced.The patient was stable prior, during, and after the event.

• Brand Name: CURRENT DR RF
• Common Device Name: 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11842087
• Report Number: 2017865-2021-18364
• Device Sequence Number: 2940140
• Product Code: LWS
• UDI-Device Identifier: 05414734501927
• UDI-Public: 05414734501927
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: 2207-36
• Device Catalogue Number: 2207-36
• Device Lot Number: 3129599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown