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 04/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 2 of 3; related manufacturer reference number: 1627487-2020-04698; related manufacturer reference number: 1627487-2020-04700.It was reported the patient experienced a loss of therapy with one extension.Diagnostics revealed high impedances, and x-rays showed disconnection between the extension and the ipg.To address the issue, the patient may be awaiting surgical intervention.Note: it is unknown which of the patient¿s extensions is disconnected, therefore both are being reported.

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.

Event Description

No surgery has been scheduled at this time.If surgery occurs, a supplement report will be submitted.

Manufacturer Narrative

The results of the investigation are inconclusive, since the device was not returned for evaluation.The device history record was reviewed, to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Device 2 of 3.Related manufacturer reference number: (b)(4); related manufacturer reference number: (b)(4).Additional information received, identified the patient's scs system extensions were replaced.And the patient's stimulation therapy was restored.

• 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: 10063757
• MDR Text Key: 191236370
• Report Number: 1627487-2020-04699
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• Combination Product (y/n): N
• PMA/PMN Number: K033757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 6733340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION; SCS IPG
• Patient Outcome(s): Other