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

Model Number 3186

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

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#: 3006705815-2017-07326.It was reported the patient was unable to increase amplitude when using the scs system.However, troubleshooting/reprogramming was able to resolve the issue.Additional information revealed the issue occurred again following an unrelated surgery and troubleshooting/reprogramming was unable to resolve the issue.The patient has turned stimulation off.As a result, the patient may undergo surgical intervention to address the issue.

Event Description

Device 1 of 2.Reference mfr.Report#: 3006705815-2017-07326.Follow-up information revealed the patent underwent surgical intervention where in the leads were explanted and replaced (reference mfr.Report#: 3006705815-2018-00314 and 3006705815-2018-00315).

• 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: jennifer shepard ; 6901 preston road; plano, TX 75024 ; 9725264657
• MDR Report Key: 7123528
• MDR Text Key: 95047289
• Report Number: 3006705815-2017-07325
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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: 07/11/2018
• Device Model Number: 3186
• Device Lot Number: A000025421
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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: 45 YR