MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION PENTA; SCS LEAD

Model Number 3228

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

Patient Problems Pulmonary Embolism (1498); Nausea (1970); Vomiting (2144)

Event Date 03/03/2013

Event Type  Injury  

Event Description

It was reported the patient went to the er with nausea and vomiting.A ct scan of the patient's scs lead did not show any anomalies.A ct scan of the thoracic was negative for csf leak.It was found the patient had developed shortness of breath and tachycardia.A small pulmonary embolus was found.The patient was prescribed medications and discharged from the hospital on (b)(6) 2013.

• Brand Name: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3641933
• MDR Text Key: 19019254
• Report Number: 1627487-2014-02096
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 3228
• Device Lot Number: 3847919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: SCS IPG, MODEL 3788; IMPLANT DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR