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); Neurological Deficit/Dysfunction (1982)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 that the patient experienced an epidural hematoma following a permanent implant on (b)(6) 2018.As a result, patient underwent an additional surgery on the same day, and scs system was explanted.

Event Description

Additional information revealed that issue of hematoma started immediately after the surgery.Patient was hospitalized for one week.Patient could not walk on their own and could only move the big toe.Patient attended rehabilitation for one week.Hematoma was removed by physician.Symptoms have resolved.

Event Description

Follow-up revealed the patient remains unable to walk since the hematoma removal procedure.

Event Description

Additional information received indicated that patient had a month of physical therapy at home.The patient had little movement in the legs and was in wheelchair prior to and after the surgery.Patient¿s condition is unchanged.

• 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
• MDR Report Key: 7406536
• MDR Text Key: 104670927
• Report Number: 1627487-2018-03321
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: 3228
• Device Lot Number: 6274262
• Other Device ID Number: 05415067017253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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: 3662 SCS, IPG
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR
• Patient Weight: 59