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

Model Number	1207-36
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the asymptomatic patient presented in clinic for an unrelated procedure.Upon attempting to loosen the set screw of the patient's implantable cardioverter defibrillator (icd), it was observed the wrench would not fit the screw.The physician also expressed concern about the silicone port removing too easily.The icd was explanted and replaced in the same procedure without issue.The patient was stable throughout.
Additional Manufacturer Narrative
Upon receipt, analysis confirmed device was at normal end of life (eol).Analysis was completed.The right ventricular set screws were stuck within the right ventricular septa, which is consistent with dislodged set screws from over loosening the set screws.The septum material was also found within the hex cavity, which would prevent insertion of the torque driver.The hex cavity was stripped.No other anomalies were found.

• Brand Name: CURRENT VR 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: 12555780
• Report Number: 2017865-2021-32265
• Device Sequence Number: 19853663
• Product Code: LWS
• UDI-Device Identifier: 05414734501941
• UDI-Public: 05414734501941
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 12/31/2009
• Device Model Number: 1207-36
• Device Catalogue Number: 1207-36
• Device Lot Number: 0002685207
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR