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 11/21/2018

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 4 of 4.Reference mfr report # 1627487-2019-02524, reference mfr report # 3006705815-2019-00672, reference mfr report # 1627487-2019-02525.It was reported the patient experienced ineffective stimulation due to inability to increase amplitude.System diagnostics revealed high impedances on all contacts.Reprogramming initially was able to provide effective stimulation.Later the patient experienced ineffective stimulation post an cervical facet injection.In turn, the patient underwent surgical intervention wherein both leads were explanted and replaced.Therapy was restored post operatively.

Manufacturer Narrative

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

Reference mfr report # 1627487-2019-02524; reference mfr report # 3006705815-2019-00672; reference mfr report # 1627487-2019-02525.

• 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: 8380882
• MDR Text Key: 137503679
• Report Number: 1627487-2019-02526
• 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,Followup
• Report Date: 07/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 3383
• Device Lot Number: 4489115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• 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
• Treatment: MODEL 3228, SCS LEAD; MODEL 3383, SCS EXTENSION; MODEL 3789, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 50