MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3086

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

Patient Problems Abscess (1690); Paresis (1998)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

Device 2 of 2, mfg report reference: 3006705815-2019-01187.It was reported that the patient experienced loss of motor function.The patient had a trial lead pull on (b)(6) 2019.It was noted there was more dried blood than expected.Following the lead pull, the patient went to the emergency room on (b)(6) 2019 due to weakness in the legs.The patient could not move both of their legs.The physician performed an additional surgery at the lead incision site.The physician stated that there was a possible abscess.The patient is currently recovering in a rehabilitation facility and is reporting full strength in the right leg and partial strength in the left leg.

Event Description

Device 2 of 2, mfg report reference: 3006705815-2019-01187.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8474328
• MDR Text Key: 140646716
• Report Number: 3006705815-2019-01188
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401555
• UDI-Public: 05414734401555
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2021
• Device Model Number: 3086
• Device Lot Number: A000072320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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 3086, SCS LEAD
• Patient Outcome(s): Hospitalization
• Patient Weight: 77