MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3257-40Q
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Fatigue (1849); Discomfort (2330)
Date of Event	07/15/2013
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
Related manufacturer reference number: 2017865-2021-00136.It was reported that lead dislodgement was observed on the right ventricular (rv) lead via fluoroscopy.Setscrew stripped in the right ventricular port was also noted.The lead could not be removed from the device header.The rv lead and the device were explanted and replaced.No complications were noted.The day after the procedure, the patient felt discomfort at the implant site, fatigue, and weakness.The patient was kept overnight.On the following day, the patient was nauseated and profoundly weak and was discharged home when the patient was feeling well.

• Brand Name: UNIFY ASSURA ICD
• 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: 11113743
• Report Number: 2017865-2021-00132
• Device Sequence Number: 1059837
• Product Code: NIK
• UDI-Device Identifier: 05414734505635
• UDI-Public: 05414734505635
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: 04/30/2014
• Device Model Number: CD3257-40Q
• Device Catalogue Number: CD3257-40Q
• Device Lot Number: 3840143
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91