MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 60 CM; SCS LEAD

Model Number 3166

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/05/2014

Event Type  Injury  

Event Description

Follow-up information revealed the patient was to be reprogrammed as the next course of action.The patient met with his physician on (b)(6) 2015.X-rays revealed one of the patient's leads is invalid and one lead has migrated.After further review, it was determined the patient's system is for occipital placement (off-label).The patient may undergo surgical intervention as the next course of action.

Event Description

Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015, where the left super orbital lead was removed due to a fracture that may have caused the impedance issues.The patient's 3 remaining leads are providing adequate coverage.

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.

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

The patient has 4 model 3166 leads (from the same lot) implanted as part of his scs system.It was reported after implant, diagnostic testing showed contacts 1-4 on one of the patient's four leads reflected a high impedance reading and is not functioning properly.The patient still has stimulation using the remaining 3 valid leads.Follow-up information revealed the patient reported he is still using the stimulation; however, it is not providing him effective pain relief.The patient will consult with the physician 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.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer Contact: jennifer shepard ; 6901 preston road; 6901 preston rd; plano, texas, TX 75024-7502
• MDR Report Key: 4366884
• MDR Text Key: 5501663
• Report Number: 1627487-2014-23843
• 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: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/28/2014
• Device Model Number: 3166
• Device Lot Number: 3881778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2012
• 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 3343, SCS EXTENSION, IMPLANT DATE; MODEL 3341, SCS EXTENSION, IMPLANT DATE
• Patient Outcome(s): Other
• Patient Age: 29 YR