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

Model Number 3383

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.

Event Description

Related manufacturer reference number 1627487-2020-31820.Related manufacturer reference number 1627487-2020-31822.It was reported that patient was experiencing ineffective stimulation due to extensions and lead disconnecting.Patient underwent surgery on (b)(6) 2020 wherein their extensions were replaced.Patient is stable.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10586574
• MDR Text Key: 208536833
• Report Number: 1627487-2020-31821
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2021
• Device Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 7011148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTENSION, 30 CM; PENTA 3 MM LEAD, 60 CM; EXTENSION, 30 CM; PENTA 3 MM LEAD, 60 CM
• Patient Outcome(s): Other
• Patient Weight: 68