MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 30CM LENGTH; SCS LEAD

Model Number 3183

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 02/20/2015

Event Type  Injury  

Event Description

It was reported the patient experienced ineffective stimulation and a change in stimulation following a recent fall.It was also reported the patient no longer has stimulation in her right arm/elbow.It was also reported the patient has invalid impedance reading on multiple lead contacts.X-rays were taken and did not reveal any anomalies.Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015 for a lead revision.However, during the procedure, the physician had difficulty repositioning the existing leads.As a result, the patient's leads were left in place.The patient may be referred for a paddle lead implant 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.

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.

Event Description

Follow-up information revealed the patient underwent surgical intervention where the patient's lead was explanted and replaced with a different model.The patient reported effective stimulation coverage postoperative and the issue is now resolved.

• Brand Name: OCTRODE LEAD KIT, 30CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4621663
• MDR Text Key: 5575754
• Report Number: 1627487-2015-23158
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 3183
• Device Lot Number: 4210966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• 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 3383, SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 53 YR