MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 90CM LENGTH; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	3189
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had ineffective stimulation with the cervical lead.A cervical lead was added on (b)(6)2024 to address the issue.
Additional Manufacturer Narrative
Date of the event is estimated.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20694546
• Report Number: 3006705815-2024-08686
• Device Sequence Number: 11707999
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: (01)05414734406147(10)4867438(17)160928
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Exemption Number: XXXX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 4867438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG.; SCS LEAD (2).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 91 KG