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 04/27/2018

Event Type  Injury  

Manufacturer Narrative

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.Abbott defers to the patient's physician regarding medical history.

Event Description

It was reported the patient has the formation of a hematoma at the site of the lead and was experiencing full body paralysis.The patient underwent surgical intervention to address the removal of the hematoma and explant of the scs system.The patient has partially recovered from the full body paralysis.Patient has feelings back in arms, however is still paralyzed from the waist down.

Event Description

Follow up information identified that the patient has entered a rehabiltation facility with paralysis from the waist down.

• 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: 7516049
• MDR Text Key: 108316048
• Report Number: 1627487-2018-04767
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Model Number: 3228
• Device Lot Number: 6346592
• Other Device ID Number: 05415067017253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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 3660, SCS IPG
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 84 YR