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

Model Number 3186

Device Problem Break (1069)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 10/22/2017

Event Type  Injury  

Manufacturer Narrative

Manufacture 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.

Event Description

Device 2 of 2.Reference mfr.Report# 1627487-2017-07075.It was reported ((b)(6)) the patient experienced a fall.The patient underwent surgical intervention on (b)(6) 2017 for possible lead fracture.During the procedure lead fracture was confirmed via x-rays.While removing the leads, the physician was unable to remove the broken part of one of the lead.The physician abandoned the procedure.The patient has no therapy at this time.Additional surgical intervention may be taken at a later date to address the issue.

Event Description

Device 2 of 2, reference mfr.Report# 1627487-2017-07075.Manufacturer patient complaint database review identified two new leads were implanted around the retained broken lead.Additional follow up revealed leads were implanted on (b)(6) 2017.Reportedly, the patient is receiving effective therapy.

Event Description

Device 2 of 2: reference mfr.Report# 1627487-2017-07075.Additional information received identified the alleged leads were explanted (explant date unknown).

• 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: 7024831
• MDR Text Key: 91803755
• Report Number: 1627487-2017-07077
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2018

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: 04/30/2017
• Device Model Number: 3186
• Device Lot Number: 5075962
• Other Device ID Number: 05414734401708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 11/06/2017; 05/17/2018
• Supplement Dates FDA Received: 11/20/2017; 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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: 48 YR