MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem No Code Available (3191)

Event Date 12/16/2014

Event Type  Injury  

Event Description

The patient has 2 leads (from the same lot) implanted as part of her scs system.It was reported the patient is without stimulation.Diagnostic testing revealed invalid impedance readings.X-rays showed the patient's right lead was fractured.The patient may undergo surgical intervention as the next course of action.

Manufacturer Narrative

(b)(4).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.

Event Description

Follow-up information revealed the patient underwent surgical intervention on (b)(4) 2015, where the patient's lead was explanted and replaced.During lead revision, the physician decided to electively explant and replace the patient's existing ipg with a new model.Effective stimulation was recaptured 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 LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer Contact: st. jude medical - neuromodulation; 6901 preston rd; plano 75040
• MDR Report Key: 4439068
• MDR Text Key: 5379654
• Report Number: 1627487-2015-23040
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 3186
• Device Lot Number: 3905812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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: MODEL 3788, SCS IPG, IMPLANT DATE; MODEL 1192 (2), SCS ANCHOR, IMPLANT DATE
• Patient Outcome(s): Other
• Patient Age: 54 YR