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

Model Number 6495J

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/12/2016

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 during the removal of these temporary pacing wires, there was a small space between the proximal electrode and the conducting wire.The electrode became detached and remained in the patient, but was subsequently removed.No other adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The event is confirmed: the gap between the outer insulation and the electrode ring is caused by the outer blue insulation which slides back on the conductor wire; this may be the consequence of the handling of the lead body during manufacturing, implant procedure, implanted time on a beating heart, and / or subsequent handling.During implant clamping the blue conductor wire and then pulling on the monofilament may also result in such situation too.The reported event is unrelated to a product failure or malfunction.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: MEDTRONIC
• 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: 5710299
• MDR Text Key: 47152828
• Report Number: 3008592544-2016-00040
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012460
• 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: 10/31/2016

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 Expiration Date: 09/28/2019
• Device Model Number: 6495J
• Device Catalogue Number: 6495J
• Device Lot Number: AAE059203F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2015
• 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