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 04/08/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

Device 1 of 4.Reference mfr.Report#: 1627487-2019-05185.Reference mfr.Report#: 1627487-2019-05186.Reference mfr.Report# 1627487-2019-05187.It was reported that one of the patient's lead had high impedance.Reprogramming was unable to resolve the issue.As a result, surgical intervention may be planned to address the issue.It is unknown which lead is related to the issue.Therefore, all the suspected devices are being reported.

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

Additional information was received that surgical intervention occurred during which the leads were explanted and replaced and the issue was addressed.

Event Description

Related manufacturer reference number,1627487-2019-05185, 1627487-2019-05186, 1627487-2019-05187.

Manufacturer Narrative

Corrections: statement was corrected from initial report."model: 3149(2), scs lead" should not have been entered in the initial report.

Event Description

Additional information was received that the 2 model # 3166 leads are the occipital leads which have high impedance and are auto-reducing.There is no allegation of deficiency against the 2 model # 3149 leads.

• 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: 8574254
• MDR Text Key: 143852037
• Report Number: 1627487-2019-05238
• Device Sequence Number: 1
• Product Code: GZF
• 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,Followup,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 3166
• Device Lot Number: 3547072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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: 3149(2), SCS LEAD; MODEL: 3166, PNS LEAD
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 77