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

Model Number 3186

Device Problem Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

It was reported the patient experienced loss of stimulation therapy.Upon evaluation of the patient's scs system, the lead impedance were invalid for multiple contacts.Consequently, the physician decided to replace the patient's octrode lead.The stimulation therapy coverage of the patient's pain was confirmed postoperatively.

• Brand Name: OCTRODE LEAD KIT, 60CM
• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8570024
• MDR Text Key: 143721436
• Report Number: 1627487-2019-05198
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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 Model Number: 3186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 06/09/2019
• Supplement Dates FDA Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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