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

Model Number	2207-30
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported field event of mechanical complication was not confirmed in the laboratory.The device was tested on the bench, and no anomalies were found.Device code: mechanical complication.
Event or Problem Description
It was reported that an unspecified issue of mechanical complication was observed on the device.Device was explanted and a new device was implanted.Patient was stable.

• Brand Name: CURRENT DR RF
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7803273
• Report Number: 2938836-2018-09780
• Device Sequence Number: 19514461
• Product Code: LWS
• UDI-Device Identifier: 05414734501910
• UDI-Public: 05414734501910
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2010
• Device Model Number: 2207-30
• Device Lot Number: 2757918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2014
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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
• Patient Age: 58 YR
• Patient Weight: 64