MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE; SCS LEAD

Model Number 3146

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/27/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report #: 1627487-2014-05270.Reference mfr report #: 1627487-2014-05271.The pt had two, 3146 leads from the same lot.It was reported the pt lost stimulation from the 3146 leads after falling.The 3286 lead provided inadequate coverage/ineffective therapy and stimulation in an unintended area, i.E., abdomen.Reprogramming to provide resolution was unsuccessful.X-rays were taken and revealed no anomalies.As a result, the pt's lead were explanted and replaced (with a 3186 lead and a 3286 lead).During the procedure, the header of the ipg was found to be damaged.In turn, the ipg was also explanted and replaced.Effective therapy was restored post-op.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: QUATTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: ahmad johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3783092
• MDR Text Key: 4433872
• Report Number: 1627487-2014-05269
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/27/2014

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: 10/01/2014
• Device Model Number: 3146
• Device Lot Number: 3847899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: SCS ANCHORS: MODEL 1192 (X3); IMPLANTED:; IMPLANTED:; SCS EXTENSION: MODEL 3341
• Patient Outcome(s): Other
• Patient Age: 48 YR