MAUDE Adverse Event Report: MEDTRONIC, INC. CAPSUREFIX; PERMANENT PACEMAKER ELECTRODE

Model Number 5076-58

Device Problems Retraction Problem (1536); Failure to Advance (2524); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Event Description

Physician, in usual fashion removed stylet from rv lead for exchange and screw was noted to be retracted under fluoro per rep and physician.A new stylet put in to reposition lead it was noted that the stylet would not go past the first 2cm of the lead and it was removed.On fluoroscopy it was noted that the lead had fully retracted but there was one coil of the helix still protruding after removal.Once out of the body coil was retracted back into lead by the nurse without difficulty.Nurse attempted to introduce stylet through lead and stylet would not advance.Medtronic rep in room and lead being sent back to medtronic for analysis.From actual note: after hemostasis was achieved, using the venogram as a reference, two punctures were made into the left axillary vein.A micropuncture set was used.Wires were advanced into the heart x2 and then exchanged for 7-french sheaths.The first sheath was used to deliver a lead, a 5076.This one had a serial number (b)(4) in the rv apex.Here r waves were 2.The stylet was removed for an exchange, and it was removed, and then the screw was retracted and a fresh stylet put in to reposition the lead.When this was done, it was noted that the stylet would not go past the first 2 cm of the lead.Therefore, this lead was removed and exchanged.On fluoroscopy, it was noted that the lead had fully retracted, but there was one coil of the helix still protruding after this lead was removed.It was serial number (b)(4).With the sheath in place, we got a new lead, serial number (b)(4).This was delivered into the heart again using a variety of stylets, and we mapped the apex.No patient harm.At the time of event, device was placed within patient's tissue.Manufacturer response for transvenous lead, 5076-58cm capsure fix (per site reporter).Field rep was present during case and product handed off to rep.

• Brand Name: CAPSUREFIX
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC, INC.; 4340 swinnea rd ms ss-46; memphis TN 38118
• MDR Report Key: 8411626
• MDR Text Key: 138519547
• Report Number: 8411626
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5076-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 56