MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 30CM; SCS EXTENSION

Model Number 3343

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 5 of 5.Reference mfr.Report#: 1627487-2019-00413, 1627487-2019-00417, 1627487-2019-00419, 1627487-2019-00423.It was reported that the patient was not receiving adequate therapy, due to high impedance.As a result, the patient's scs system was explanted to address the issue.Date of explant is currently unknown.

Event Description

Device 5 of 5 mfr.Reference report#:1627487-2019-00413, 1627487-2019-00417, 1627487-2019-00419, 1627487-2019-00423.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 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: 8228508
• MDR Text Key: 132424887
• Report Number: 1627487-2019-00424
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000852
• 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
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 3343
• Device Lot Number: 3959388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2013
• 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: 3166, SCS LEAD (X3); MODEL: 3343, SCS EXTENSION
• Patient Outcome(s): Other