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

Model Number 3383

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

Device 2 of 2.Reference mfr report: 1627487-2019-05147.It was reported the patient experience ineffective therapy due to high impedances.Reprogramming was unable to resolve the issue.X-ray imaging indicated slight pullout at the lead and extension connection.In turn, surgical intervention was undertaken on (b)(6) 2019 wherein multiple attempts were made to reconnect the extension and lead.However, high impedances were observed.Intra operative testing revealed normal impedance on the lead.As such, the extension was explanted and replaced with a new extension resolving the issue.Reportedly, therapy was achieved in the pain area.

Event Description

Device 2 of 2.Reference mfr report: 1627487-2019-05147.

• 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: 8568863
• MDR Text Key: 143686769
• Report Number: 1627487-2019-05148
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2020
• Device Model Number: 3383
• Device Lot Number: 6702190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• 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: MODEL 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 75