MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495J

Device Problem Sticking (1597)

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

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the product specimen has been received for analysis; however, device evaluation is currently in progress.Conclusion: upon completion of device evaluation, a supplemental report will be submitted.

Event Description

Medtronic received information that during the use of this temporary pacing lead, a portion of the lead became stuck to the myocardium on a small gap between the proximal electrode and blue line.No additional intervention and no adverse patient effects were reported.

Manufacturer Narrative

Analysis: a product was returned for analysis, with several pictures of the device provided for review, but no lot number was identified.Without the lot number, a review of the device history record associated with this event cannot be performed.There was a gap between the outer insulation and the electrode ring.This was caused by the outer blue insulation, which slides back on the conductor wire.On the returned product, that gap exposed a 1 mm gap between the blue insulation and outer conductor wire, well within design specifications.This situation may be slightly different than the situation observed after product implant, as the blue insulation slid easily on the conductor wire, at the time of the product analysis.This 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 and / or subsequent handling.During implant clamping the blue lead body conductor wire and then pulling on the monofilament may result in such situation, too.The product instructions for use state that ¿additional stretching of the blue monofilament coil is not required.Do not overstretch the coiled portion of the blue monofilament coil.¿ conclusion: the review of the returned product confirms the product shows up within the design requirement.The distal side of the returned product may have received some abnormal stress which may have result in the situation observed.The reported event is unrelated to a product failure or malfunction.

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 HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5877077
• MDR Text Key: 52163577
• Report Number: 2025587-2016-01249
• 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: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6495J
• Device Catalogue Number: 6495J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• 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