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

Model Number	5820
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	11/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient reported feeling symptoms of fatigue following a non-specified procedure in hospital.The patient inquired about pacemaker settings due to her fatigue as she believed the pacemaker was not pacing like it was prior to her unrelated procedure.The patient was set to receive programming changes by an abbott representative as arranged by her clinic.Recommendations for the patient to contact their hospital to inquire about follow up with the scheduled abbott representative were made to address potential programming changes.
Event or Problem Description
New information received notes the patient did not contact her clinic in (b)(6) 2023 regarding potential symptoms or issues with the pacemaker.The patient was interrogated in (b)(6) 2023 during a follow up in clinic and the pacemaker was found to have reached the normal elective replacement indicator (eri).There were no complaints or issues reported by the patient during her visit in clinic in (b)(6) 2023.The patient received a routine changeout due to normal eri on (b)(6) 2024 which was successful.The patient had a follow up on (b)(6) 2024 and was doing well with no complaints.

• Brand Name: ZEPHYR 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: 18188551
• Report Number: 2017865-2023-72946
• Device Sequence Number: 7275542
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: 05414734501613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 02/28/2017
• Device Model Number: 5820
• Device Lot Number: A000010220
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2015
• 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: TENDRIL LEAD; TENDRIL LEAD
• Patient Age: 48 YR
• Patient Sex: Female