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

Model Number 3286

Device Problem Difficult to Advance (2920)

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

Event Date 06/17/2014

Event Type  Injury  

Event Description

It was reported the physician was unable to implant the lead during the revision procedure due to excessive scarring in the epidural space.Reportedly, the existing lead was explanted and replaced with a surgical lead in order to accommodate the space.Subsequently, the surgical lead was connected into the existing extensions and impedances were within normal range.However, the physician was not successful with accurate placement of the surgical lead into the cervical region and opted to abandon the case.

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: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 3946403
• MDR Text Key: 20861706
• Report Number: 1627487-2014-01451
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: 3286
• Device Lot Number: 4093097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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
• Treatment: IMPLANT:; IMPLANT:; IMPLANT:; SCS IPG: MODEL 3788; SCS EXTENSION: MODEL 3383 (2); SCS LEAD: MODEL 3219
• Patient Outcome(s): Other
• Patient Age: 61 YR