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

Model Number 3186

Device Problem Fracture (1260)

Patient Problems Inadequate Pain Relief (2388); Device Embedded In Tissue or Plaque (3165)

Event Date 12/02/2017

Event Type  Injury  

Manufacturer Narrative

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.Manufacturer defers to the patient¿s physician regarding medical history.

Event Description

It was reported the patient stopped receiving stimulation approximately six months ago.The patient underwent surgical intervention on (b)(6) 2017 to replace an inoperable ipg (reference mfr.Report: 3006705815-2017-01685) and an x-ray was taken and revealed the lead was fractured.The lead was removed and replaced, however a portion of the lead was unable to be explanted and a portion of the lead remains in the epidural space.Therapy has been resumed and patient is receiving effective stimulation.

• 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: 7138143
• MDR Text Key: 95493174
• Report Number: 1627487-2017-08589
• 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
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2008
• Device Model Number: 3186
• Device Lot Number: 56651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2006
• 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 3788, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 77 YR