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

Model Number 3186

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

It was reported the patient complained of pain in his back again.Upon evaluation of the patient's scs system the impedance showed high for the first lead.Reprogramming was unable to resolve the issue.Consequently, the physician decided to turn off the patient's scs system and schedule a replacement of the patient's lead.

Event Description

Follow up information received identified the patient's lead was replaced with a new one.The stimulation therapy was confirmed and covering the pain area again.The patient was fine postoperative.

Manufacturer Narrative

Corrected data: - method, results and conclusion codes corrected.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8547808
• MDR Text Key: 143021615
• Report Number: 1627487-2019-04993
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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,Followup,Followup
• Report Date: 09/13/2019

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 Expiration Date: 05/31/2017
• Device Model Number: 3186
• Device Lot Number: 5115954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/06/2019; 07/15/2019; 09/12/2019
• Supplement Dates FDA Received: 05/30/2019; 07/16/2019; 09/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2015
• 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