MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

Device Problems Difficult to Advance (2920); Impedance Problem (2950)

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

Event Date 11/20/2014

Event Type  malfunction  

Event Description

Device 1 of 3.Reference mfr.Report# 1627487-2014-20499.Reference mfr.Report# 1627487-2014-20500.

Event Description

Device 1 of 3 reference mfr.Report# 1627487-2014-20499 reference mfr.Report# 1627487-2014-20500.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Manufacturer Narrative

Result:the complaint of ¿invalid impedance¿ was not confirmed.The octrode leads and extension were returned in good condition and passed continuity and stress testing.As received, some of the rj45 connectors on the cables were cracked.However, when functionally tested, the cables passed continuity and stress testing on all channels.The field scenario was created by connecting the returned leads, extensions and trial cables together and checking continuity.Continuity passed in all cases.No physical or functional anomaly was observed that would contribute to the reported complaint of invalid impedance.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

Device 1 of 3.Reference mfr.Report# 1627487-2014-20499.Reference mfr.Report# 1627487-2014-20500.It was reported during the patient's ((b)(6)) trial procedure the physician observed invalid impedances when the lead was connected to the extension which in turn was connected to the trial cable and to the mts.The physician tried troubleshooting using multiple scs extensions to no avail.As a result, the procedure was abandoned.Also the physician experienced difficulty inserting the leads into the extensions.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston road; plano TX 75024
• MDR Report Key: 4341237
• MDR Text Key: 5305879
• Report Number: 1627487-2014-20498
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 3383
• Device Lot Number: 4648408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2015; 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2014
• 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