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

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Inadequate Pain Relief (2388)

Event Date 10/27/2017

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: 3006705815-2017-07125.It was reported the patient begin to experience pain in the right leg whether the scs system stimulation was on or off.Reportedly, the md suspected the patient's scs lead was causing nerve irritation.Surgical intervention was taken and the patient's right lead was moved down from t8 to t9.Follow up identified the patient was well and reported no more pain in the right leg that kept her from walking.

Event Description

Device 1 of 2.Reference mfr report: 3006705815-2017-07125.

Event Description

Device 1 of 2: reference mfr report: 3006705815-2017-07125.Additional information received identified the patient had reported to the physician she was still having pain and falling.Subsequently, the patient had the scs system removed.

• Brand Name: OCTRODE 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: arnulfo ochoa ; 6901 preston road; plano, TX 75024 ; 9723098090
• MDR Report Key: 7049626
• MDR Text Key: 92653990
• Report Number: 3006705815-2017-07124
• 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,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 3186
• Device Lot Number: A000039603
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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 (X2), SCS ANCHOR; MODEL 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 77 YR