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

Model Number 3386

Device Problem High impedance (1291)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Device information for the explanted extension is unknown at this time.Further information was requested but not received.

Event Description

Device 3 of 3.Related manufacturer reference number: 1627487-2019-07328.Related manufacturer reference number: 1627487-2019-07329.It was reported the patient experienced a loss of stimulation after suffering a fall at the ipg site.Diagnostics revealed high impedances, and the physician suspected a fracture in either the ipg or extension.To address the issue, the physician performed a revision surgery on (b)(6) 2019 wherein the ipg and extension were replaced.Intraoperative impedances were still high, so the physician then explanted and replaced the lead, which resolved the issue.

Manufacturer Narrative

The reported high impedance was not confirmed.The extension was returned with damage to the spacers preventing the terminal end from being inserted into the header of the returned ipg or a lab ipg.Despite the damage observed, the extension passed all electrical tests.The header passed all mechanical and lead fitment tests.As the extension could not be re-inserted into the header of the ipg, it was concluded the terminal end of the extension was damaged after it was explanted.How the extension was damaged could not be conclusively determined.No physical or functional anomaly that existed prior to explant that would contribute to the reported issue was observed.

Event Description

Device 3 of 3 related manufacturer reference number: 1627487-2019-07328.Related manufacturer reference number: 1627487-2019-07329.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8731738
• MDR Text Key: 149104162
• Report Number: 1627487-2019-07330
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402330
• UDI-Public: 05414734402330
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: 3386
• Device Catalogue Number: 3386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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: SCS IPG; SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 51 YR