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

Model Number 3186

Device Problem Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 3.Reference mfr.#: 1627487-2018-06554, 1627487-2018-06557.It was reported the patient was not receiving needed therapy due to an impedance issue related to the leads.It was also reported the patient did not maintain the ipg as recommended, thus, making it inoperable over time.As a result, the scs system was explanted and replaced.Therapy restored post-op.

• 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
• Manufacturer Contact: michael mccane ; 9725268297
• MDR Report Key: 7692416
• MDR Text Key: 114135261
• Report Number: 1627487-2018-06552
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 3186
• Device Lot Number: 4134550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2013
• 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
• Patient Age: 45 YR