MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

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 after a fall.Invalid impedance was measured upon system diagnostics and no stimulation was possible.Subsequently, surgical intervention was taken and the patient's lead was replaced with a new lead was successfully implanted.Stimulation therapy was restored and the issue was resolved.

• Brand Name: OCTRODE LEAD KIT, 90CM 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: 8414852
• MDR Text Key: 138630750
• Report Number: 1627487-2019-03370
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/13/2019

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: 04/03/2020
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 6381587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2018
• 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: 47 YR