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

Model Number 3186

Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991)

Event Date 12/01/2013

Event Type  Injury  

Event Description

The patient has two leads with the same lot number.It was reported the patient is experiencing overstimulation that causes jerking or muscle spasms due to falling.Lead diagnostics showed invalid impedances.Reprogramming provided resolution.Follow-up revealed, the patient fell again.Lead diagnostics revealed both leads have invalid impedances.Reprogramming did not provided resolution.The patient was referred to a neurosurgeon for further evaluation.The physician ordered a ct scan for evaluation.The patient may undergo surgical intervention to address the issue.

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: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3601888
• MDR Text Key: 16912080
• Report Number: 1627487-2014-25060
• 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: 12/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: 3186
• Device Lot Number: 4189868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2013
• Initial Date FDA Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2003
• 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 ANCHORS: MODEL 1192 (X2); IMPLANT DATE:; IMPLANT DATE:; SCS IPG: MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 32 YR