MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Inadequate Pain Relief (2388); Numbness (2415)

Event Date 12/01/2016

Event Type  Injury  

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

Device 2 of 3.Reference mfr.Report#: 1627487-2017-03676, reference mfr.Report#: 1627487-2017-03770.It was reported the patient sporadically feels pain and overstimulation sensations at the ipg site that causes numbness in her hand/fingers.The patient also stated she has fallen.In addition, the patient stated she has not felt therapy in over 6 months.Subsequently, the patient may undergo surgical intervention to address the issues.Please note: the patient's leads have been added to this record as new devices (devices 2 and 3).

Event Description

Device 2 of 3, reference mfr.Report#: 1627487-2017-03676.Reference mfr.Report#: 1627487-2017-03770.Follow-up information revealed the patient continues to feel pain (described by the patient as a burning sensation) at the ipg site.The patent is also concerned that multiple mris may have damaged the ipg.The patient also believes the ipg is too close to her ribs and she has received injections to assist with the pain.The physician is monitoring the pain.In addition, the patient states the stimulation is uncomfortable.

Event Description

Device 2 of 3 :reference mfr.Report#: 1627487-2017-03676 , reference mfr.Report#: 1627487-2017-03770.Follow-up information revealed the patient underwent surgical intervention wherein the ipg was explanted and replaced with another model.The ipg site was also relocated.Effective therapy was restored post-operative and the issue is resolved.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 6701342
• MDR Text Key: 79629090
• Report Number: 1627487-2017-03769
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

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: 12/28/2016
• Device Model Number: 3189
• Device Lot Number: 4899324
• Other Device ID Number: 05414734401715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 08/23/2017; 09/19/2018
• Supplement Dates FDA Received: 09/19/2017; 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2014
• 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 1192 (2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 56 YR