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

Model Number 3228

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/20/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2014-21248.It was reported the pt experienced ineffective back stimulation in addition to discomfort at the ipg pocket due to its location.Subsequently, the pt underwent surgical intervention to explant the ipg.While attempting to explant the scs lead, it was hung up on the lamina and the tails of the lead came apart as the physician pulled on it.As a result, the physician left part of the lead implanted.

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: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston road; plano, TX 75024 ; 9725264823
• MDR Report Key: 3782888
• MDR Text Key: 19804784
• Report Number: 1627487-2014-21249
• 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: 03/28/2014

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: 3228
• Device Lot Number: 4103499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/17/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR