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

Model Number 3186

Device Problem High impedance (1291)

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr report: 1627487-2018-04454.It was reported the patient experienced loss of stimulation therapy from her scs system after she hit the area of her low back in the bathtub.Reportedly, the stimulation resume on the left leg but not the right leg.X-ray taken showed the leads appeared to be in the same location as previously and properly aligned in the ipg header.Reprogramming of the patient's scs system was performed and stimulation therapy was captured in both legs, however, the patient complained of a "shocking" sensation in the area where her leads are anchored.The patient turned the stimulation therapy off and, was advised to leave the stimulation off until she heard from her physician.Follow up identified the patient had both of her leads replaced.Effective stimulation therapy was reportedly achieved postoperatively.

Event Description

Device 2 of 2.Reference mfr report: 1627487-2018-04454.Follow up information identified the patient had both of her scs leads replaced.The patient reported receiving effective stimulation therapy postoperatively.

• 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: 7485587
• MDR Text Key: 107309948
• Report Number: 1627487-2018-04455
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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: 05/28/2016
• Device Model Number: 3186
• Device Lot Number: 4591282
• Other Device ID Number: 05414734406130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Patient Outcome(s): Other
• Patient Weight: 64