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

Model Number 3186

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain the patient's weight.The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Device 2 of 2 reference mfr report#: 3006705815-2020-30488.It was reported the patient has been receiving ineffective therapy.The patient's right lead was determined to be fractured.As a result, the patient's plans to undergo surgical intervention on a later date.Note: both of the patient's leads are being reported because it's unknown which device is the right side lead.

Manufacturer Narrative

Patient's weight was obtained via follow-up.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Device 2 of 2 reference mfr report#: 3006705815-2020-30488 follow-up revealed the patient's right lead was explanted and replaced to address the issue.Note: both of the patient's leads are being reported because it's unknown which device is the right side lead.

• 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
• MDR Report Key: 10353682
• MDR Text Key: 201356717
• Report Number: 3006705815-2020-30489
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000063387
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3186.
• Patient Outcome(s): Other
• Patient Weight: 68