MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION DUAL EXTENSION; SCS EXTENSION

Model Number 3343

Device Problems Detachment Of Device Component (1104); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/27/2014

Event Type  Injury  

Event Description

Device 2 of 3.Ref mfr reports: 1627487-2014-05720, 05722.On 09/26/2014, the pt was implanted with an scs system for off-label use.It was reported invalid contacts were present the following day.X-rays were taken and revealed the extensions had pulled out of the ipg header.As a result, the pt underwent surgical intervention on (b)(6) 2014.During the procedure, the last contact from one of the extensions was found to be inside the ipg header.In turn, the doctor explanted and replaced the extensions (with different models) along with the ipg.Optimal stimulation was restored post-op.

Manufacturer Narrative

Udi (di): (b)(4).Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: DUAL EXTENSION
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4202033
• MDR Text Key: 5043641
• Report Number: 1627487-2014-05721
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/27/2014

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: 01/01/2016
• Device Model Number: 3343
• Device Lot Number: 4427942
• Other Device ID Number: 05414734402293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2014
• Initial Date FDA Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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: IMPLANT DATE:; SCS LEADS, MODEL: 3169 (X2); SCS LEADS, MODEL: 3166 (X2); IMPLANT DATE:; SCS ANCHOR, MODEL: 1192 (X4); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 26 YR