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

Model Number 3288

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Tingling (2171); Discomfort (2330)

Event Date 10/15/2013

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report #1627487-2014-01292.It was reported, the pt is experiencing overstimulation and discomfort when stimulation is turned on.Reportedly, residual stimulation and a tingling sensation can be felt when stimulation is turned off.Subsequently, the pt states stimulation turns on by itself at night.Troubleshooting revealed the scs system is working properly and stimulation is managing the pain effectively.A physician consult will be the next course of action.

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: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 3799269
• MDR Text Key: 18796423
• Report Number: 1627487-2014-01291
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2014
• Device Model Number: 3288
• Device Lot Number: 3794703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 64 YR