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

Model Number 3228

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Stops Intermittently (1599)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 03/01/2014

Event Type  Injury  

Event Description

It was reported the patient experienced a fall approximately 4 months ago landing on her back.Presently, stimulation is intermittent and in addition, the patient feels a shocking sensation.Reprogramming was completed with impedance readings within normal range.An x-ray was ordered as the next course of action.

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: 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: 4013075
• MDR Text Key: 4689132
• Report Number: 1627487-2014-01522
• 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: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: 3228
• Device Lot Number: 3437019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS ANCHOR: MODEL 1194 (2); IMPLANT DATE:; SCS IPG: MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 25 YR