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

Model Number	3207-36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/29/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint was received with return of the device.Failure event observed during analysis.Final analysis revealed silicone material inside the aring, atip, lvtip, and rv/svc set screw hex cavities.This material prevented full insertion of the torque driver in the hex cavity and resulted in difficulty tightening the set screw.Abbott conducted a review of complaint files under a non-product capa and identified that a report was required to be filed as a result of the subject event.Distributed devices are not affected by the capa.Additionally, no new risks were identified, and no product-related actions are required as a result of this report submission.Furthermore, product performance trending is not impacted by this report, and no new mitigation actions are required as a result of this report.
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: PROMOTE RF CRT-D
• 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: 8104097
• Report Number: 2017865-2018-17739
• Device Sequence Number: 19130411
• Product Code: NIK
• UDI-Device Identifier: 05414734501958
• UDI-Public: 05414734501958
• Combination Product (Y/N): N
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: Other
• Device Expiration Date: 01/31/2010
• Device Model Number: 3207-36
• Device Lot Number: 2752495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2015
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1