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

Model Number 3086

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

Patient Problems Hematoma (1884); Ambulation Difficulties (2544)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information.Based on the information provided a device problem was not identified.As a result, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Event Description

Related manufacturer reference numbers: 3006705815-2021-04130.It was reported that during or after a trial implant procedure, the patient experienced a hematoma.The patient lost the ability to walk and control the bowels.As a result, the patient was hospitalized, the trial leads were removed earlier than originally planned on an unknown date, and surgery occurred to remove the hematoma.The patient was discharged from the hospital and was prescribed physical therapy.The hematoma, inability to walk, and inability to control the bowels, have resolved.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS TRIAL 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12351977
• MDR Text Key: 267624958
• Report Number: 3006705815-2021-04129
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: A000110478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2021
• 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
• Patient Outcome(s): Other
• Patient Weight: 64