MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

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

Patient Problems Hematoma (1884); Paralysis (1997)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported the patient underwent a permanent implant procedure on (b)(6) 2018.In post-op the patient was doing well, had good coverage, and showed no signs of adverse events.Later the same day the surgery center reported the patient was paralyzed from the waist down.The patient was taken into emergency surgery where a large hematoma was found.The physician cleaned out the hematoma and placed the lead back in place.The patient was transferred to the hospital where she regained feeling and movement in her legs.The patient was released from the hospital on (b)(6) 2018.

• Brand Name: PENTA 3MM LEAD, 60 CM
• 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
• Manufacturer Contact: kimberly goode ; 6901 preston road; plano, TX 75024 ; 9723098541
• MDR Report Key: 7853863
• MDR Text Key: 119482336
• Report Number: 1627487-2018-08339
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• 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
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Model Number: 3228
• Device Lot Number: 6472113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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 1194 (2), SCS ANCHOR; MODEL 3660, SCS IPG
• Patient Outcome(s): Hospitalization; Other