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

Model Number 3186

Device Problems Detachment Of Device Component (1104); Impedance Problem (2950)

Patient Problem Fall (1848)

Event Date 06/25/2014

Event Type  Injury  

Event Description

The pt has a scs system which includes two leads from the same lot.It was reported the pt suffered a fall last year and sustained multiple injuries.Lead diagnostics showed invalid impedance.The sjm rep was unable to reprogram the system due to the programmer not being available.The pt is currently receiving stimulation.F/u info identified xrays were taken and reprogramming was able to provide effective stimulation.Surgical intervention was undertaken on (b)(6) 2014 to electively replace the ipg.The leads were not fully engaged into the header of the ipg.Lead diagnostics revealed no anomalies, hence the leads were not replaced.The pt is now experiencing effective stimulation.

Manufacturer Narrative

Sjm has limited info 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: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4024360
• MDR Text Key: 16864290
• Report Number: 1627487-2014-26642
• 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: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2011
• Device Model Number: 3186
• Device Lot Number: 2861857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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 DATE:; SCS ANCHOR: MODEL 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 74 YR