MAUDE Adverse Event Report: ST. JUDE MEDICAL ¿ NEUROMODULATION UNKNOWN

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

Patient Problems Aspiration/Inhalation (1725); Vomiting (2144)

Event Date 12/27/2013

Event Type  Injury  

Event Description

It was reported during the patient's permanent scs implant procedure the patient vomited.The patient was hospitalized due to concerns the patient may have aspirated the vomit.A chest x-ray was performed and the patient was kept overnight.The patient was released the next day on (b)(6) 2013.X-ray results are unknown at this time.

Manufacturer Narrative

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

• Brand Name: UNKNOWN
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston road; plano, TX 75024 ; 9723098090
• MDR Report Key: 3601805
• MDR Text Key: 4190205
• Report Number: 1627487-2014-02056
• 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: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2013
• 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
• Patient Outcome(s): Hospitalization