MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

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

Patient Problem Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Abbott has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Abbott defers to the patient's physician regarding medical history.In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.

Event Description

Device 2 of 3.Reference mfr report #: 1627487-2017-08269, reference mfr report #: 1627487-2017-08271.It was reported that the patient experienced numbness in their right leg following a permanent implant procedure on (b)(6) 2017.As a result, the patient was hospitalized for a week and stimulation was turned off.An abbott representative met with the patient on (b)(6) 2017 and stated that the issue had been resolved.Patient has effective therapy.

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.During processing of this incident, attempts were made to obtain complete patient information.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS LEAD
• 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
• MDR Report Key: 7110797
• MDR Text Key: 94619914
• Report Number: 1627487-2017-08270
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: 11/30/2017
• Device Model Number: 3189
• Device Lot Number: 5326551
• Other Device ID Number: 05415067017314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization