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

Model Number	PM2110
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented remotely via merlin.Net.Transmission revealed that the pacemaker exhibited diagnostic anomaly.No intervention was performed.There were no patient consequences.
Additional Manufacturer Narrative
The reported event of incorrect measurement was not confirmed, device not triggering replacement alert at eri level was confirmed.The pacer was received with battery voltage at elective replacement indicator (eri) level.Eri was not triggered when battery reached eri level due to eri trims programmed at 2.52 v.Electrical and mechanical analysis performed under nominal conditions indicated normal functionality with normal data measurement.Longevity assessment was performed, based on average drain current, and the device exceeded projected longevity indicating normal battery depletion.
Event or Problem Description
New information received noted that the pacemaker was explanted and replaced.Patient status was not known.
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
New information received noted that the patient was in stable condition.

• Brand Name: ACCENT DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17947398
• Report Number: 2017865-2023-49867
• Device Sequence Number: 7897824
• Product Code: NVZ
• UDI-Device Identifier: 05414734503600
• UDI-Public: 05414734503600
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/13/2023

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: 03/31/2015
• Device Model Number: PM2110
• Device Lot Number: 4266905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: Not provided; 11/10/2023; 12/05/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/09/2023; 12/01/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2013
• 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: MASTER SERIES CAVGJ; PASSIVE PLUS; TENDRIL SDX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female