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

Model Number 3186

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2016-04164.It was reported the patient experienced ineffective/unintended stimulation following a car accident.System diagnostics determined high impedances on the leads.X-rays confirmed the lead migration and possible lead fracture.An sjm representative tried reprogramming and was able to restore acceptable stimulation at the time.However, the issue recurred.Additionally, the patient experienced nausea with stimulation.As a result, surgical intervention was taken wherein the leads were explanted and replaced with a single lead which resolved the issue.Reportedly, effective therapy was restored postoperatively.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2: reference mfr.Report# 1627487-2016-04164.

• 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
• MDR Report Key: 5872254
• MDR Text Key: 51961811
• Report Number: 1627487-2016-04163
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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: 06/28/2016
• Device Model Number: 3186
• Device Lot Number: 4676953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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 3789, SCS IPG
• Patient Outcome(s): Other