MAUDE Adverse Event Report: MEDTRONIC, INC. UNIPOLAR TEMPORARY ATRIAL PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6492

Device Problems Material Fragmentation (1261); Physical Resistance (2578)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the product specimen has been received; however, this device evaluation is in progress.Conclusion: should additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that while removing this temporary pacing lead from the patient 6 days post implant, there was significant resistance and the lead broke, leaving a part of the lead in the patient.No intervention was performed and no adverse patient effects were reported.It is unknown how many days the lead was implanted.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the two pieces of products were received tightly knotted together, most likely during operating surgery.The distal stainless electrode and a piece of blue monofilament coil which provides fixation while the lead is implanted were missing from both products.The inspection after decontamination of the two broken leads indicated that the fractured conductor wire appeared irregular, most likely due to fatigue and elongation stress.These products have been submitted to severe handling, most likely at the implant procedure.This is not recommended by the instruction for use of this device.No root cause for the fracture had been identified or can be assigned to a manufacturing issue.Conclusion: 3 products were returned, 2 broken pieces and one sterile not used product.The event is confirmed on the two broken pieces of lead.The inspection of the non-used product confirmed that the returned product of the same batch (bbd027206f) is conforming to design specifications.A review of the device history record of batch (bbd027206f) associated with this event had been performed without identifying any potential of a manufacturing issue.The inspection of the two broken leads indicates that the fractured conductor wires appear irregular, most likely due to fatigue and elongation stress.These products have been submitted to severe handling, most likely at the implant procedure (two tight knots and loops had been applied to the two lead bodies).Although the instruction for use indicates that the physician may choose to vary the lead fixation procedure in accordance with judgment and experiences, the selected fixation method should always allow for later pacing lead removal.It also indicates in the lead handling section to not excessively bend, kink, twist, or stretch the pacing lead.Excessive bending, kinking, twisting or stretching may damage the junctions, pacing lead body and insulation resulting in device failure and / or loss of therapy.No root cause had been identified for the fracture, other items may have affected the performance of the 6492 like, but not limited to: location of implant, patient tissue condition, loss of implant location, the implant technique, etc.There is no trend for this event type.In the past 5 years no fracture issue had been reported with unipolar temporary atrial pacing lead model 6492.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNIPOLAR TEMPORARY ATRIAL PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway, ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC, INC.; 710 medtronic parkway, ne; minneapolis MN 55432
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5710289
• MDR Text Key: 48130671
• Report Number: 3008592544-2016-00039
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6492
• Device Catalogue Number: 6492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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