MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 30 CM; SCS LEAD

Model Number 3153

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.Date of event is estimated.

Event Description

Related manufacturer report number: 1627487-2019-07709, 1627487-2019-07713, 1627487-2019-07714, 1627487-2019-07715.It was reported that during device assessment, one of the leads displayed high impedance.Surgical intervention may be pending to address the issue.It is unknown which lead is liable so both leads are 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

Related manufacturer report number: 1627487-2019-07709, 1627487-2019-07713, 1627487-2019-07714, 1627487-2019-07715 new information received indicates that two of the leads were explanted and replaced on (b)(6) 2019.It is unknown which leads were explanted so all three leads are reported.Adequate stimulation was established post-operatively.

• Brand Name: QUATTRODE LEAD, 3/6MM, 30 CM
• Type of Device: SCS 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: 8769841
• MDR Text Key: 150366102
• Report Number: 1627487-2019-07711
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• 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: 07/23/2019

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: 10/31/2007
• Device Model Number: 3153
• Device Lot Number: 46233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2005
• 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
• Patient Outcome(s): Other
• Patient Weight: 91