MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM; SCS LEAD EXTENSION

Model Number 3341

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  Injury  

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 reference number: 1627487-2019-10152, 1627487-2019-10153.It was reported the diagnostics reports during the programming indicated high impedance on the supra orbital lead.X-rays revealed that the lead pulled out of the extension header.As a result, patient underwent surgical intervention on (b)(6) 2019 where in the lead was re-connected to the extension.Issue resolved post-operatively.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• Type of Device: SCS LEAD 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: 8977297
• MDR Text Key: 156976836
• Report Number: 1627487-2019-10155
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402279
• UDI-Public: 05414734402279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930536
• 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
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2019
• Device Model Number: 3341
• Device Lot Number: 6152919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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 SCS LEAD (2)
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 68