MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3086

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/13/2018

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 1 of 2: reference mfr.Report#:3006705815-2018-02205.It was reported during a trial procedure on (b)(6) 2018, a portion of one lead broke off in the patient's epidural space.As such , the patient will be referred to a neurosurgeon to address the issue.Please note: it is unknown which lead is liable.Therefore all suspected devices are being reported.

Event Description

Device 1 of 2 : reference mfr.Report#:3006705815-2018-02205.Follow-up information revealed the reason that the leads may have become broken is the physician managed to cause the lead to become engaged with the sharp tip of the epidural needle implanted into the patient during the trial.As the physician attempted to full extract the lead back into the needle, the outer casing of the lead separated from the rest of the lead and remained in the patient¿s epidural space.In addition, the patient does not desire to undergo any further interventions at this time.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: jennifer shepard ; 6901 preston road; plano, TX 75024 ; 9725264657
• MDR Report Key: 7857962
• MDR Text Key: 119639540
• Report Number: 3006705815-2018-02204
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401555
• UDI-Public: 05414734401555
• 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
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2020
• Device Model Number: 3086
• Device Lot Number: A000050673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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