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

Model Number	1207-36
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that during a replacement procedure the supraventricular cardiac lead set screw was observed to be stripped.Multiple wrenches were used in attempt to remove the screw but failed.The lead was capped on (b)(6) 2019.The device was explanted and replaced.No clinical complications occurred as a result of the procedure.
Additional Manufacturer Narrative
The reported event of setscrew anomaly was not confirmed in the laboratory.Bench testing was performed, and no anomalies were found.The set screws engage with the torque wrench and leads normally.A tug test was performed, and the leads behaved as expected.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found the patient notifier to be nonfunctional.The cause of the event was determined to be a motor anomaly.
Additional Manufacturer Narrative
Correction: concommitant device date should have been (b)(6) 2019 rather than (b)(6) 2019.

• Brand Name: CURRENT VR 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: 8765722
• Report Number: 2938836-2019-05074
• Device Sequence Number: 14071830
• Product Code: LWS
• UDI-Device Identifier: 05414734501941
• UDI-Public: 05414734501941
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2020

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: 01/31/2010
• Device Model Number: 1207-36
• Device Catalogue Number: 1207-36
• Device Lot Number: 2695910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 01/29/2020; 01/29/2020
• Initial Report FDA Received Date: 07/06/2019
• Supplement Report FDA Received Date: 01/29/2020; 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1