MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	7170Q/65
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient presented remotely via merlin.Net.Review of the transmission revealed non-sustained right ventricular oversensing (nsrvo) alerts were delivered due to the right ventricular (rv) lead oversensing noise.No changes or intervention was reported.There were no patient consequences.
Event or Problem Description
New information received notes this patient received a cardiomems (cardio micro-electro- mechanical system) implant on 15 mar 2024 with successful calibration and physiologic readings.It was noted on 18 mar 2024 three-day post implant, that sensor readings could not be obtained from the cardiomems implant.Trouble shooting was performed with a request for additional imaging to confirm the cardiomems sensor placement.Right ventricular waveforms were observed during the reading.The sensor was confirmed during radiology to have migrated from the left pulmonary artery (pa) to the right ventricle (rv) via fluoroscopy.The site planned to leave the sensor in place.On 14 jun 2024 the patient's pacemaker leads were noted to be failing, and this was believed to be related to the cardiomems.According to the physician, the right ventricular (rv) lead was picking up inappropriate ectopy.The site believed the cardiomems sensor was laying on the rv lead.The site was considered extraction.On 18 jun 2024 an attempt to remove the cardiomems sensor was performed but was unsuccessful.The physician elected to abort the removal of the sensor and no issues or harm to the patient were reported.The site reported no adverse consequences related to lead failure and were deliberating right ventricular icd lead replacement.
Additional Manufacturer Narrative
Related manufacturer report #: 3004936110-2024-00418 on cardiomems hf sensor delivery system.
Event or Problem Description
New information received notes there was no complaint on the rest of the implantable cardioverter defibrillator (icd) system just on the right ventricular (rv) lead due to its proximity to the cardiomems sensor that had migrated into the right ventricle.The rest of the system worked well.The sensor and icd system remained implanted.No programming changes were made because the noise on the rv lead was intermittent and infrequent.The patient experienced no side effects, the physician therefore opted for no intervention, just close monitoring.The patient was stable.
Event or Problem Description
New information received notes the patient received an inappropriate shock due to oversensing noise on the right ventricular (rv) lead.The qrs complexes were wide and double counting on the discrimination channel.The patient was not in good condition for a right ventricular (rv) lead revision, so the physician was to consider programming changes to prevent the shocks when the rv lead noise re-appeared.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 19297891
• Report Number: 2017865-2024-41293
• Device Sequence Number: 6016229
• Product Code: NVY
• UDI-Device Identifier: 05414734503266
• UDI-Public: (01)05414734503266(10)4335709(17)141130
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 11/30/2014
• Device Model Number: 7170Q/65
• Device Lot Number: 4335709
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 09/18/2024; 01/06/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 09/18/2024; 09/19/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2013
• 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: CM2000 CARDIOMEMS; GALLANT; GALLANT HF ICD; QUARTET LV LEAD; TENDRIL SDX RA LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 105 KG