MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 30CM LENGTH; SCS LEAD

Model Number 3183

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

Patient Problem Abscess (1690)

Event Date 12/01/2016

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.(b)(4).

Event Description

It was reported the patient underwent an scs trial on (b)(6) 2016.Reportedly, when the patient returned on (b)(6) 2016 to remove the leads, the tail end of the lead was no longer there and the physician believed the lead had fallen out because the tape was undone.Follow up identified the lead did not fall out as originally thought.X-rays showed the lead was sitting ventral to the spinal cord hitting the c7 pedicle.The physician was concerned the patient may have an abscess.Additional follow up identified the lead was explanted, the lead appeared intact.The physician stated the patient's issues are not resolved at this point.

• Brand Name: OCTRODE LEAD KIT, 30CM 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: 6206879
• MDR Text Key: 63358095
• Report Number: 1627487-2016-06606
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 3183
• Device Lot Number: 5255745
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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 Age: 47 YR