MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) ISOFLEX OPTIM LEAD; Permanent Defibrillator Electrodes

Model Number	1944/52
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, the right atrial (ra) lead suture sleeve did not securely hold the lead body despite multiple attempts at suturing and retracted backward.The physician subsequently selected a screw-in right ventricular (rv) lead; however, the lead exhibited a helix malfunction.As a result, neither the ra lead nor the rv lead was implanted.The physician then selected another screw-in lead, which was successfully implanted in the right atrium.The patient remained in stable condition.
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, the right atrial (ra) lead suture sleeve failed to securely hold the lead body despite multiple suturing attempts and retracted backward.The ra lead was not implanted and was replaced with a screw-in lead.The patient remained in stable condition.
Additional Manufacturer Narrative
Further information was requested but not received.
Additional Manufacturer Narrative
Correction: the correct event description in section b5 should have been "it was reported that the patient presented for an implant procedure.During the procedure, the right atrial (ra) lead suture sleeve failed to securely hold the lead body despite multiple suturing attempts and retracted backward.The ra lead was not implanted and was replaced with a screw-in right ventricular (rv) lead.The patient remained in stable condition.", rather than "it was reported that the patient presented for an implant procedure.During the procedure, the right atrial (ra) lead suture sleeve did not securely hold the lead body despite multiple attempts at suturing and retracted backward.The physician subsequently selected a screw-in right ventricular (rv) lead; however, the lead exhibited a helix malfunction.As a result, neither the ra lead nor the rv lead was implanted.The physician then selected another screw-in lead, which was successfully implanted in the right atrium.The patient remained in stable condition." manufacturer report number 2017865-2026-17937 was inadvertently reported in section h10 and should not have been included, as it was not relevant to the reported event.

• Brand Name: ISOFLEX OPTIM LEAD
• Common Device Name: Permanent Defibrillator Electrodes
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50446420
• Report Number: 2017865-2026-17937
• Device Sequence Number: 13202314
• Product Code: NVY
• UDI-Device Identifier: 05414734502320
• UDI-Public: (01)05414734502320(10)P000251999(17)290228
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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 Model Number: 1944/52
• Device Lot Number: P000251999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 09/05/2026; 09/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/29/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• 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
• Patient Sex: Unknown