MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Device information, implant dates and explant dates are unknown at this time.Additional information has been requested but not yet received.Investigation results will be provided in the final report.

Event Description

Device 6 of 7.Reference mfr.Report#: 1627487-2019-05885, 1627487-2019-05886, 1627487-2019-05887, 1627487-2019-05888, 1627487-2019-05889, 1627487-2019-05891, this patient has 2 systems.It was reported x-rays revealed the patient¿s leads on the right side had migrated, and the patient¿s leads on the left side had pulled out of the ipg header.The patient reported no falls or traumatic event.To address the issue, the physician performed surgical intervention (exact date unknown) where he verified the right leads did migrate.He explanted and replaced the leads on the right side and connected them to extensions.When looking at the leads on the left side, the physician reported they seemed to have torn out of the ipg with wiring and contact material torn out of the ipg.He also explanted and replaced these leads and connected them to extensions.The ipg associated with the lead pull out was also explanted and replaced.Postoperatively, effective therapy was reported.Two extensions were explanted for unknown reason.

Event Description

Device 6 of 7; reference mfr.Report#: 1627487-2019-05885, 1627487-2019-05886, 1627487-2019-05887, 1627487-2019-05888, 1627487-2019-05889, 1627487-2019-05891.It was reported that surgical intervention did take place on (b)(6) 2019.

Manufacturer Narrative

The date of implant has been provided.The reported event of lead migration was not confirmed.This issue cannot be confirmed with product analysis.As received, both extensions were missing channel 1 terminal end lead electrode.The missing terminal end electrodes were stuck in the ipg header.The other lead channels were functionally tested and passed.It cannot be determined whether the detached electrodes occurred in vivo or during the explant procedure.

Event Description

Reference mfr.Report#: 1627487-2019-05885; 1627487-2019-05886; 1627487-2019-05887; 1627487-2019-05888; 1627487-2019-05889; 1627487-2019-05891.

• Brand Name: EXTENSION, 30CM
• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8625590
• MDR Text Key: 145559372
• Report Number: 1627487-2019-05890
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K000852
• 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,Followup
• Report Date: 08/07/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 3383
• Device Lot Number: 6491894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 05/28/2019; 07/10/2019
• Supplement Dates FDA Received: 06/17/2019; 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• 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
• Treatment: SCS EXTENSION; SCS IPG; SCS LEAD (X4)
• Patient Outcome(s): Other