MAUDE Adverse Event Report: ABBOTT OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number LDA210Q/65

Device Problems Over-Sensing (1438); Retraction Problem (1536); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  Injury  

Event Description

During an in-clinic follow-up, crosstalk was observed on the right ventricular (rv) lead.The suspected cause of the event was dislodgement of the rv lead.While repositioning the rv lead, the helix could not retract.A new rv lead was used to resolve the event.The patient was stable.

Manufacturer Narrative

As received, a complete lead was returned in one piece.The reported event of helix mechanism issue was confirmed.Visual examination found the helix retracted and clogged with blood/tissue.X-ray examination of the connector region found the inner coil over torqued consistent with procedural damage.X-ray examination of the helix mechanism found no anomalies or distortion of the helix that would have contributed to helix mechanism issue reported in the field.The cause of the reported event of helix mechanism issue was isolated to the over torqued inner coil and the helix being clogged with blood/ tissue.The reported event of oversensing was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.No anomalies were noted with the exception of procedural damage.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18606245
• MDR Text Key: 334096367
• Report Number: 2017865-2024-03213
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Model Number: LDA210Q/65
• Device Lot Number: A000120362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention