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

Model Number 1192

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient had an additional lead implanted (reference mfr report#: 1627487-2014-25558).During the procedure, the doctor was unable to implant one of the two anchors (from the same lot) due to the patient's anatomy.The second lead was implanted successfully.In turn, the procedure was extended an hour.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history an 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: ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4085058
• MDR Text Key: 17697360
• Report Number: 1627487-2014-05618
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: 1192
• Device Lot Number: 3985749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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
• Patient Age: 73 YR