MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

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

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Abbott care team called the patient and the patient reported both device and leads were removed.Patient stated they had their system explanted about 2 years ago due to discomfort from the stimulator when it was on or off.Patient no longer has any abbott device implants.The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.

Event Description

Related manufacturer reference number: 3006705815-2019-03829.1627487-2019-11301.1627487-2019-11303.It was reported that the patient had their system explanted approximately 2 years ago due to uncomfortable stimulation.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• 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: 9158791
• MDR Text Key: 161339088
• Report Number: 1627487-2019-11302
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960728
• 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: 10/04/2019

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: 01/28/2016
• Device Model Number: 3383
• Device Lot Number: 4418815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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