MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE CRT-P; DEFIBRILLATOR, CARDIOVERTER, CARDIAC RESYNCHRONIZATION (CRT-D)

Model Number	PM3120
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect Measurement (1383); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that battery depletion was suspected to be faster than anticipated on the pacemaker.The patient was stable.
Event or Problem Description
New information received notes that the battery issue was observed during a half yearly checkup.A drastic change was seen in the estimated longevity during this six month period.The estimated longevity was 6.6 years in (b)(6) 2022 but the longevity estimate in (b)(6) 2022 was 1.7 years.No major difference in usage was seen.The change was noted after a programmer software upgrade in (b)(6) 2022 and may have been linked to programmer function.The pacemaker remained implanted and was scheduled for a six month re-evaluation in clinic.The patient had no symptoms and was stable throughout the interrogation.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
Event or Problem Description
New information received notes the physician beleived this was a programmer related over estimation of longevity issue.The device remained implanted.

• Brand Name: ALLURE CRT-P
• Common Device Name: DEFIBRILLATOR, CARDIOVERTER, CARDIAC RESYNCHRONIZATION (CRT-D)
• 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: 15147878
• Report Number: 2017865-2022-16505
• Device Sequence Number: 14841215
• Product Code: NIK
• UDI-Device Identifier: 05414734507882
• UDI-Public: 05414734507882
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030035
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2022

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: 01/31/2017
• Device Model Number: PM3120
• Device Catalogue Number: PM3120
• Device Lot Number: A000009082
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 09/14/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEFT VENTRICULAR LEAD; RIGHT ATRIAL LEAD; RIGHT VENTRICULAR LEAD
• Patient Sex: Unknown