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

Model Number	2207-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented to the emergency department after receiving a vibratory notifier.It was then discovered that the implantable cardioverter defibrillator prematurely reached elective replacement indicator (eri).The device was explanted and replaced on (b)(6) 2018.During the procedure, fluoroscopy revealed that the right ventricular lead had an insulation breach and was capped and replaced.The patient was stable and was discharged.
Additional Manufacturer Narrative
A longevity calculation was performed based on the programmed settings and usage data.The calculation showed the battery depletion was normal.However, it was found that the longevity estimate given to the field by the programmer was incorrect.The device was at the elective replacement indicator (eri) when received.
Event or Problem Description
Manufacturer reference number: 2017865-2019-04711.

• 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
• MDR Report Key: 8219712
• Report Number: 2017865-2019-00260
• Device Sequence Number: 1657204
• Product Code: LWS
• UDI-Device Identifier: 05414734501927
• UDI-Public: 05414734501927
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2011
• Device Model Number: 2207-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/25/2019; 01/25/2019; 03/28/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/01/2019; 02/04/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention