MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-02375.It was reported that the patient presented in clinic for unrelated procedure.The physician noticed a small area of infection around the pacemaker.The pacemaker and inactive right atrial (ra) lead were explanted.The patient was stable.
Additional Manufacturer Narrative
Correction to h6 codes type of investigation code should have been "analysis of production records".
Additional Manufacturer Narrative
Additional information device will not be returned for analysis.Update to h6 codes.
Event or Problem Description
Device will not be returned for analysis.

• Brand Name: ACCENT SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13423203
• Report Number: 2017865-2022-02374
• Device Sequence Number: 14790918
• Product Code: NVZ
• UDI-Device Identifier: 05414734502740
• UDI-Public: 05414734502740
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: PM1110
• Device Catalogue Number: PM1110
• Device Lot Number: 3933651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/18/2022; 03/21/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/19/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ISOFLEX S LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male