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

Model Number 3186

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/28/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report#1627487-2015-08031; reference mfr report#1627487-2015-08032.It was reported the patient is without stimulation.X-rays results reveal the leads have pulled out of the ipg header.Surgical intervention may be undertaken at a future date.

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

Device 1 of 5.Reference mfr report#1627487-2015-08031, reference mfr report#1627487-2015-08032, reference mfr report#1627487-2015-08104, reference mfr report#1627487-2015-08105.It was reported surgical intervention was undertaken, explanting and replacing the two extensions and ipg.Effective therapy was achieved postoperatively.The issue is resolved.Note: new device reports 3 and 4 are being added for the extensions.

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: OCTRODE LEAD KIT, 60CM 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 road; plano TX 75024
• MDR Report Key: 4471102
• MDR Text Key: 5189125
• Report Number: 1627487-2015-08029
• 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
• Report Date: 02/03/2015

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: 07/28/2016
• Device Model Number: 3186
• Device Lot Number: 4718172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 01/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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 3383(2), SCS EXTENSION, IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 67 YR