MAUDE Adverse Event Report: ST JUDE MED - NEUROMODULATION SINGLE EXTENSION; SCS EXTENSION

Model Number 3383

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/03/2014

Event Type  Injury  

Event Description

It was reported the pt (b)(6) experienced a loss of stimulation.The pt denied suffering any trauma prior to the loss of stimulation.Diagnostic testing indicated invalid impedance readings, but x-rays did not reveal any anomalies.Surgical intervention was undertaken and intraoperative testing isolated the issue to the lead extension.A kink was also observed in the extension.The extension was explanted and replaced.Further diagnostic testing indicated impedance readings within normal limits effective therapy was recaptured for the pt following the procedure.

Manufacturer Narrative

Results: the complaint of "invalid impedance" was confirmed.The extension was examined microscopically.Wires detached from the electrodes were observed in the header.Conductivity testing showed that all channels were electrically open.As there was no other damage to the extension's header, and the invalid impedance was observed prior to the revision, the broken wires are consistent with sudden tensile overstress the extension was subjected to while it was inside the pt.Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: SINGLE EXTENSION
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST JUDE MED - NEUROMODULATION; plano TX
• Manufacturer Contact: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 4132740
• MDR Text Key: 18064851
• Report Number: 1627487-2014-15698
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2014
• Device Model Number: 3383
• Device Lot Number: 3722692
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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): Other