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

Model Number 3186

Device Problems Disconnection (1171); High impedance (1291)

Patient Problems Fall (1848); Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Date 04/23/2018

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 3: reference mfr.Report: 1627487-2018-04681, reference mfr.Report: 3006705815-2018-01077.It was reported the patient experienced ineffective stimulation from the scs thoracic system after the patient fell.Diagnostics revealed high impedances, and x-rays confirmed the leads have pulled out of the ipg header.Reprogramming attempts have been unsuccessful, therefore the patient may be awaiting surgical intervention.

Event Description

Additional information received indicated that the patient underwent surgical intervention on an unknown date a couple years ago wherein the scs system was explanted and replaced with another manufacturer's, nuvectra, system.Further information is unavailable at this time.

Manufacturer Narrative

The event of leads pulled out of header was reported to abbott.The patient experienced ineffective stimulation from the scs thoracic system after the patient fell.Patient was evaluated and high impedance was detected during an impedance check.X-rays confirmed the leads have pulled out of the ipg header.Reprogramming attempts were unsuccessful.The scs system was explanted and replaced with another manufacturer's system.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, 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: 7495584
• MDR Text Key: 107633673
• Report Number: 1627487-2018-04682
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3186
• Device Lot Number: 4772694
• Other Device ID Number: 05414734406130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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 1192 (X2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 102