MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/21/2019

Event Type  Injury  

Event Description

Device 3 of 4: reference mfr report #3006705815-2019-00472.Reference mfr report #3006705815-2019-00473.Reference mfr report #1627487-2019-02830.It was reported that the patient could not place the ipg in the surgery mode.During reprogramming the leads displayed high impedances.Also, x rays showed the leads were potentially fractured.As a result, surgical intervention was undertaken wherein the leads and the anchors were explanted and replaced.Therapy was restored post-operatively.The physician had cut the anchors during the original implant and therefore the anchors are made reportable.

Manufacturer Narrative

Corrected data: the patient date of birth was incorrectly reported as apr 3, 1949 the correct date of birth is filed in this report.Implant date was inadvertently reported as (b)(6) 2018 in the initial report.The correct date of implant has been added to this report.

Event Description

Device 3 of 4 reference mfr report#3006705815-2019-00472; reference mfr report#3006705815-2019-00473; reference mfr report#1627487-2019-02830.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• 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: 8394664
• MDR Text Key: 137957468
• Report Number: 1627487-2019-02829
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• 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: 04/01/2019

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: 02/16/2020
• Device Model Number: 1192
• Device Lot Number: 6304345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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 1192, SCS ANCHOR; MODEL 3168(2) SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 81