MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 60CM; SCS EXTENSION

Model Number 3386

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported ((b)(6)) the patient was undergoing surgical intervention to address impedance issues.During the procedure, one of the extension electrode contacts broke off inside the ipg header.As the ipg was replaced, the issue was resolved.

Manufacturer Narrative

Implant date for concomitant device is unknown: model 3772, scs ipg.

Event Description

Additional information received indicated the incident occurred on (b)(6) 2018.

• Brand Name: EXTENSION, 60CM
• 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: joanne story ; 9725264875
• MDR Report Key: 7883596
• MDR Text Key: 120516339
• Report Number: 1627487-2018-08824
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402330
• UDI-Public: 05414734402330
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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: 04/09/2020
• Device Model Number: 3386
• Device Catalogue Number: 3386
• Device Lot Number: 6388095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• 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
• Patient Outcome(s): Other