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

Model Number 3383

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/05/2019

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#: 1627487-2019-03722; reference mfr.Report#: 1627487-2019-03723.It was reported one of the patient's lead tails was completely out of one of the extensions and the other lead was almost out of the extension (confirmed via x-rays).In turn, the patient underwent surgical intervention on (b)(6) 2019 wherein both extensions were revised.However, system diagnostic revealed invalid and high impedances.As a result, both extensions were explanted and replaced which resolved the issue.Therapy was restored post operatively.

• 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: 8441224
• MDR Text Key: 139480677
• Report Number: 1627487-2019-03724
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• 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
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: 3383
• Device Lot Number: 6472104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• 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: 39 YR