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

Model Number 3186

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

Patient Problems Skin Erosion (2075); Inadequate Pain Relief (2388)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: model 3186, scs lead ; therapy date not available as the exact date of event is not known.

Event Description

Related manufacturer reference number: 1627487-2019-06765.It was reported that the patient experienced lead migration followed by skin erosion after having an scs system implanted in 2015.The patient requested to have the entire system explanted approximately two years ago on an unknown date.No other information is known.

• Brand Name: OCTRODE LEAD KIT, 60CM 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8688648
• MDR Text Key: 147645624
• Report Number: 1627487-2019-06764
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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: Physician
• Type of Report: Initial
• Report Date: 06/11/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 3186
• Device Lot Number: 4993936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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