MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3189

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

Patient Problem Apnea (1720)

Event Date 02/20/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-02172.It was reported during a procedure to revise the pt's scs lead, the pt stopped breathing.The procedure was interrupted in order to address the pt not breathing.After a brief moment the pt recovered his breathing.The physician became concerned the interruption may had compromised the sterility of the devices and decided to explant the pt's entire scs system.No further issues were experienced and the pt was reportedly doing well after the procedure.

Manufacturer Narrative

Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: OCTRODE
• 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: 3696989
• MDR Text Key: 21876856
• Report Number: 1627487-2014-02171
• 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: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2014
• Device Model Number: 3189
• Device Lot Number: 3741870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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; SCS ANCHOR: MODEL 1192 (X2); IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 29 YR