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

Model Number 3186

Device Problems Migration or Expulsion of Device (1395); Device Stops Intermittently (1599); Low impedance (2285)

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Date 02/20/2013

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2014-02432.It was reported the patient experienced a strong sensation when he increased his stimulation amplitude.The patient stated he felt the sensation in his leg which then moved close to his scs ipg site.A sjm representative met with the patient and a system diagnostics showed multiple lead contacts with low impedances.The representative reprogrammed the patient's scs system.On (b)(6) 2014, the patient complained his scs stimulation was intermittent.A system diagnostics show low impedances again.X-rays taken revealed the patient's scs leads migrated down around the ipg.Follow up on (b)(6) 2014 identified the patient underwent surgical intervention to revise his scs leads.The physician repositioned the leads and secured them with anchors.The patient reported receiving effective stimulation therapy postoperative.

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; 6901 preston rd.; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3940488
• MDR Text Key: 4577738
• Report Number: 1627487-2014-02433
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: 3186
• Device Lot Number: 424269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: SCS IPG: MODEL 3788; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 72 YR