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 02/12/2019

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 2 of 3: reference mfr report#1627487-2019-02997, reference mfr report#1627487-2019-03002.It was reported that the patient was unable to experience adequate stimulation.Lead diagnostics revealed high impedances on most of their contacts.Surgical intervention is pending to address the issue.

Manufacturer Narrative

The implant date was inadvertently missing in the initial report.The implant date is added to the additional report-1.

Event Description

Device 2 of 3: reference mfr report #1627487-2019-02997.Reference mfr report #1627487-2019-03002.Additional information received identified that surgical intervention was undertaken wherein the scs system was explanted and replaced.Reportedly the lead was fractured in multiple places, with one contact out of the lead completely.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: 8386850
• MDR Text Key: 137708209
• Report Number: 1627487-2019-03001
• 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: 03/28/2019

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: 09/28/2016
• Device Model Number: 3383
• Device Lot Number: 4864024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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 3219, SCS LEAD; MODEL 3383, SCS EXTENSION
• Patient Outcome(s): Other
• Patient Weight: 61