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

Model Number	5480
Medical Device Problem Codes	Premature Discharge of Battery (1057); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the pacemaker had exhibited premature battery depletion.The device was explanted and replaced.The patient was stable.Further information was requested but not received.
Additional Manufacturer Narrative
Additional information: upon receiving new information, the pulse generator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
Event or Problem Description
New information received indicated there was no allegation of premature battery depletion.The device was explanted for normal depleted battery.The patient was stable.

• Brand Name: IDENTITY ADX VDR
• 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: 15567300
• Report Number: 2017865-2022-40924
• Device Sequence Number: 2984728
• Product Code: LWP
• UDI-Device Identifier: 05414734006927
• UDI-Public: 05414734006927
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 5480
• Device Catalogue Number: 5480
• Device Lot Number: S000011384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown