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); Pain (1994)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported following the scs system implant procedure the patient experienced pain under the ribs.Stimulation was discontinued for time being.The physician had a ct scan done which was inconclusive.Later the patient was admitted to the hospital and underwent surgical exploratory procedure on (b)(6) 2018 to investigate the cause.Hematoma was found which was evacuated.The patient is doing fine and therapy has been restored.

• 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: 7373987
• MDR Text Key: 103575699
• Report Number: 1627487-2018-02922
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2019
• Device Model Number: 3228
• Device Lot Number: 5986607
• Other Device ID Number: 05415067017253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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): Other
• Patient Age: 63 YR