MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	LDA220Q/52
Medical Device Problem Codes	High impedance (1291); Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient received a vibratory alert and presented in clinic.Upon interrogation, the right ventricular lead was noted with high, out of range high voltage impedance.No intervention was made, and the patient was later brought back into the clinic.The device was interrogated without issue, and programming changes were made.The patient was stable and would be monitored remotely.
Additional Manufacturer Narrative
The reported event of high defib impedance was not confirmed.As received, a partial lead (only connector portion) was returned in one piece.Unable to perform impedance test due condition of the lead, as received.Electrical testing did not find any indication of conductor fractures.Electrical testing found shorting between inner coil and cables consistent with procedural damage.Additional findings unrelated to the reported event: visual examination found an external insulation abrasion breaching the optim sheath proximal to suture sleeve tie impression.The silicone insulation beneath was intact and undamaged.The cause of the external insulation abrasion is consistent with friction to device can.
Event or Problem Description
The right ventricular (rv) lead was returned.Further information received notes the patient was deceased.The rv lead was most likely returned following this event.There is no known allegation from a health professional that suggests the death was related to the rv lead.The cause of death is unknown.No further information is available at this time.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• 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: 11355717
• Report Number: 2017865-2021-09209
• Device Sequence Number: 3383213
• Product Code: NVY
• UDI-Device Identifier: 05414734507349
• UDI-Public: 05414734507349
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 08/31/2017
• Device Model Number: LDA220Q/52
• Device Catalogue Number: LDA220Q-52
• Device Lot Number: S000022617
• 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: 02/08/2021
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2016
• 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: Death
• Patient Age: 64 YR
• Patient Sex: Female