MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

Note: only one lead was returned.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: 1627487-2018-09113.It was reported ((b)(6)) the patient was undergoing a routine trail lead pull on (b)(6) 2018.One of the leads lost four contacts, and the contacts remained in the patient, as verified via x-rays.There is no current plan for patient to undergo further surgical intervention to retrieve the lost contacts.Note: both of the patient's leads are being reported because it is unknown which lead is liable.

Event Description

Device 1 of 2: reference mfr.Report: 1627487-2018-09113.

• Brand Name: OCTRODE LEAD KIT, 90CM 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
• Manufacturer Contact: joanne story ; 9725264875
• MDR Report Key: 7899788
• MDR Text Key: 121432045
• Report Number: 1627487-2018-09112
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 10/18/2018

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: 06/12/2020
• Device Model Number: 3189
• Device Lot Number: 6486507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2018
• 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