MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 0.5

Model Number 6149

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388); Shaking/Tremors (2515)

Event Date 11/05/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr.Report: 1627487-2014-21753, reference mfr.Report: 1627487-2014-21754.It was reported the patient (b)(6) received a dbs system which comprises two leads and two extensions; each pair has the same lot number.The patient reported experiencing overstimulation along the right side of his body upon moving his head.Additionally, the patient's tremor has increased.Diagnostics indicated high and low impedance values.Reprogramming is ineffective in addressing the stimulation issue.X-rays were inconclusive in confirming lead position/ipg header connections.The patient confirmed lack of symptoms when the system was turned off.Surgical intervention may take place to further troubleshooting the issue.

Event Description

Device 1 of 3 reference mfr.Report: 1627487-2014-21753 reference mfr.Report: 1627487-2014-21754 follow-up identified diagnostics indicate invalid impedances on the left lead.Additionally, the patient experiences dizziness when stimulation amplitude is increased.An x-ray and additional programming is pending to address the issue.

Manufacturer Narrative

This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.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

Device 1 of 3.Reference mfr.Report: 1627487-2014-21753.Reference mfr.Report: 1627487-2014-21754.Follow-up identified the patient experiences parasthesia only when he turns his head to the right.Additionally, the patient stated experiencing loss of balance on his left foot and struggles to climb stairs.The patient also feels a burning sensation on the top of his head and describes 'tension' on his lead that has increased in the past four weeks.The physician decided to proceed with surgical intervention with the intent to explant the system in order to perform an mri.However, a fracture was observed on the left extension at the time of surgery.At this time, the physician explanted and replaced the extension.Intra-operative testing indicated invalid/high and low impedances upon connecting the new extension to the ipg.Fluid was also noted on the left lead.The physician also retracted the right lead as it was implanted deep.The physician decided to leave the dbs system implanted as is and continue monitoring progress via reprogramming.

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: 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 0.5
• Type of Device: DBS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, tx
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; st. jude medical - neuromodulation; 6901 preston road; plano, tx 75024 750
• MDR Report Key: 4288098
• MDR Text Key: 5054525
• Report Number: 1627487-2014-21752
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2015

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: 01/28/2015
• Device Model Number: 6149
• Device Lot Number: 3913349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 12/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2014; 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• 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
• Patient Outcome(s): Other