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

Model Number 3186

Device Problems High impedance (1291); Therapy Delivered to Incorrect Body Area (1508)

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

Event Date 09/28/2015

Event Type  Injury  

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

It was reported, the patient fell recently.As a result, the patient only feels stimulation coverage in her left flank.Prior to the fall, the stimulation covered the patient's left lower extremity stump and phantom limb pain.Reprogramming was unable to recapture the patient's original area of pain.In addition, diagnostic testing revealed high impedance readings on multiple lead contacts.X-rays did not show any anomalies.The patient may undergo surgical intervention as the next course of action.

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 a trial procedure where the physician's attempt was unsuccessful at capturing more stimulation coverage of the patient's phantom left foot due to scar tissue.As a result, the procedure was abandoned.(reference mfr.Report#: 1627487-2015-09017).It was noted post-operative, reprogramming was able to provide the patient with stimulation coverage from her hip/waist on the left, down the leg, to the ankle, but was unable to provide coverage in the phantom left foot.In addition, it was reported no further interventions are planned for the patient at this time.

Event Description

The patient had 2 leads (from the same lot) implanted as part of her scs system.Follow-up information revealed the patient underwent surgical intervention where the patient's leads were explanted and replaced by a single penta lead.In addition, during the same procedure, the physician elected to explant and replaced the patient's ipg to take advantage of new technology.The patient reported effective stimulation therapy postoperative.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston road; plano TX 75024
• MDR Report Key: 5174765
• MDR Text Key: 29178961
• Report Number: 1627487-2015-23629
• 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,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2010
• Device Model Number: 3186
• Device Lot Number: 174579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2008
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR