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

Model Number 1192

Device Problem Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/01/2014

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr report 1627487-2014-12736, 12737.Note: the pt received 2 leads from the same lot.It was reported the pt lost stimulation in her feet.Reprogramming was unable to provide stimulation to the pt's toes.An x-ray revealed the right lead had moved down and right anchor had a kink in it.Diagnostic tests showed all impedances are in the normal range.The physician is using other modalities to treat her pain.

Manufacturer Narrative

Sjm has limited information 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: ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 4252660
• MDR Text Key: 5016509
• Report Number: 1627487-2014-12738
• 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: 10/08/2014

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: 06/01/2015
• Device Model Number: 1192
• Device Lot Number: 4107459
• Other Device ID Number: 05414734400671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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
• Treatment: IMPLANT DATE:; SCS IPG: MODEL 3716
• Patient Outcome(s): Other
• Patient Age: 49 YR