MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number 3146

Device Problems High impedance (1291); Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/12/2015

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr.Report#: 1627487-2015-23062.Reference mfr.Report#: 1627487-2015-23063.It was reported the patient underwent surgical intervention on 02/05/2015, where both leads were explanted and replaced.The 2 new leads were connected to the existing ipg.The patient reported effective stimulation therapy postoperative.

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#: 1627487-2015-23062, reference mfr.Report#: 1627487-2015-23063.It was reported the patient was unable to feel stimulation.Diagnostic testing revealed high impedance readings.X-rays were ordered and revealed the lead appears to be partially pulled from the ipg header.The patient will undergo surgical intervention 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, 3/4MM, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; jennifer shepard; plano, texas 75024
• MDR Report Key: 4488907
• MDR Text Key: 5559686
• Report Number: 1627487-2015-23061
• 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: 02/05/2015

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: 01/31/2007
• Device Model Number: 3146
• Device Lot Number: 35533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 02/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2005
• 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: 84 YR