MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 60 CM; PNS LEAD

Model Number 3166

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/11/2019

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 1 of 2.Reference mfr.Report#: 1627487-2019-03949.It was reported the patient did not receive effective therapy due to high impedances on the occipital leads.As a result, the patient underwent surgical intervention on 11 march 2019 wherein the occipital leads were disconnected and two additional leads were implanted.Effective therapy was restored post procedure.

Event Description

Device 1 of 2: reference mfr.Report#: 1627487-2019-03949.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 60 CM
• Type of Device: PNS LEAD
• 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: 8460434
• MDR Text Key: 140182061
• Report Number: 1627487-2019-03948
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 05414734406109
• UDI-Public: 05414734406109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: 3166
• Device Lot Number: 6381593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• 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: 3166, PNS LEAD
• Patient Outcome(s): Other