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

Model Number 3186

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/09/2017

Event Type  Injury  

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.

Event Description

Device 3 of 3.Reference mfr.Report # 1627487-2017-06534, reference mfr.Report # 1627487-2017-06552.It was reported that the patient was experiencing loss of therapy.Impedance check revealed high impedance in both leads.X rays revealed leads pulled out of the ipg header.As a result, surgical intervention may be pending to address the issue.

Event Description

Device 3 of 3: reference mfr report#1627487-2017-06552, reference mfr report#1627487-2017-06534.Additional information identified that surgical intervention was undertaken ((b)(6) 2018) wherein the leads were inserted back in the ipg header, however high impedances were noted on all contacts.The leads were pulled back and the header was cleaned.Leads were tested with epg.Impedance showed normal values.Post operatively, effective therapy was confirmed.

Event Description

Device 3 of 3: reference mfr report#1627487-2017-06552; reference mfr report#1627487-2017-06534.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 6986104
• MDR Text Key: 90506075
• Report Number: 1627487-2017-06555
• Device Sequence Number: 1
• Product Code: GZF
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 3186
• Device Lot Number: 3161537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2010
• 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 Age: 70 YR