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

Model Number 3186

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

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

It was reported that the during the lead replacement procedure (reference mfr report# 1627487-2018-09120), the top contact of the lead was broken.As a result, a new lead was implanted and the procedure was completed.

Event Description

Additional information received identified that the physician noted the lead looked scratched or sheared after trying to insert it so he retracted and didn¿t use the lead.Nothing came off the lead and nothing was left in patient.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8091276
• MDR Text Key: 127943591
• Report Number: 1627487-2018-11769
• 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,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 3186
• Device Lot Number: 3175257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2010
• 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 1192, SCS ANCHOR; MODEL 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 100