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

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with the investigation results will be provided in final report.

Event Description

Reference mfr.Report #1627487-2019-04953.It was reported the patient underwent a lead trial on (b)(6) 2019 for left leg pain.During the trial, the patient complained the leg pain was worse with the trial than prior to the implant.The physician explanted one trial lead on (b)(6) 2019 and continued the trial with only the one remaining lead implanted.The patient reported the left leg pain reduced but was still worse than pre-trial leg pain.The patient then experienced incontinence, as well as left leg weakness.The physician opted to explant the second lead on (b)(6) 2019 and ordered an mri, the results of which were unremarkable.The physician plans to continue to monitor the patient, and no further intervention is currently planned.

Event Description

Related manufacturer reference number: 1627487-2019-04953.

• 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: 8555250
• MDR Text Key: 143248125
• Report Number: 1627487-2019-04952
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Model Number: 3186
• Device Lot Number: 6793961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2019
• 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
• Treatment: MODEL: 3186, SCS LEAD
• Patient Outcome(s): Other