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

Model Number 3383

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/04/2019

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 3 of 3.Reference mfr report# 1627487-2019-02537.Reference mfr report# 1627487-2019-02644.It was reported that the patient¿s scs system was reducing by itself.When the patient attempted increasing the strength the system would turn off by itself.Lead diagnostics indicated that the lead contacts displayed high impedances.As a result, surgical intervention may be undertaken to address the issue.

Event Description

Device 3 of 3.Reference mfr.Report #1627487-2019-02537.Reference mfr.Report #1627487-2019-02644.Additional information received that lead and extensions were explanted and replaced on (b)(6) 2019.

Event Description

Device 3 of 3.Reference mfr report#1627487-2019-02537.Reference mfr report#1627487-2019-02644.Additional information received identified that therapy was restored.

• 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: 8366312
• MDR Text Key: 137005527
• Report Number: 1627487-2019-02645
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 3383
• Device Lot Number: 3841858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2012
• 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 3228, SCS LEAD; MODEL 3383, SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 52