MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problems Break (1069); Kinked (1339); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2015-23211.Follow-up information revealed the patient met with the sjm representative on (b)(6) 2015.Multiple lead contacts were low, but were in higher range of 170-190 ohms.It was also noted the patient has effective stimulation coverage.

Manufacturer Narrative

Results: the complaint for ¿invalid impedance¿ was confirmed.As received, the returned octrode lead had kink with multiple internal wires broken.When aligned with a swift lock anchor, the breakage corresponds to a distal end fracture.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 2.Reference mfr.Report#: 1627487-2015-23211.It was reported diagnostic testing revealed one of the patient's leads were invalid.The sjm representative was able to program around the invalid contacts.Follow-up information revealed the patient's lead was kinked/broken.Subsequently, the patient underwent surgical intervention on (b)(6) 2015, where one of the patient's leads was explanted and replaced.It was also reported the patient's stimulation was restored for both of the patient's legs postoperative.However, the patient desired more effective back coverage.The patient was given new programs to address the issue.It is unknown which lead had the issue.Therefore, both are being reported.

Manufacturer Narrative

Udi (di): (b)(4).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: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4674311
• MDR Text Key: 5823702
• Report Number: 1627487-2015-23210
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 3186
• Device Lot Number: 4420233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• 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
• Treatment: MODEL 1192 (2), SCS ANCHOR; MODEL 3788, SCS IPG
• Patient Outcome(s): Other