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

Model Number 3086

Device Problems Device Damaged by Another Device (2915); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report#: 1627487-2014-05419.On (b)(6) 2014, the pt underwent a trial procedure.During the procedure, the doctor damaged one of the leads due to bending and improper use of the stylet.Another lead was used to complete the procedure.In turn, the procedure was extended by an hour.Both leads are being reported because it is unk which lead was not implanted.

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: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston road; plano, TX 75024 ; 9725264667
• MDR Report Key: 3909714
• MDR Text Key: 21725442
• Report Number: 1627487-2014-05418
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: 3086
• Device Lot Number: 4519013
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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): Other
• Patient Age: 68 YR