MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION PENTA

Model Number 3228

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Tingling (2171); Inadequate Pain Relief (2388)

Event Date 11/12/2013

Event Type  Injury  

Event Description

It was reported, the patient received programming but stimulation was not achieved in the right side of her pain area.Most of the stimulation was in the left hand and forearm.The primary pain area is across the back between the shoulder blades on both sides.Some stimulation coverage was achieved on the left side of the shoulder blade area.At the next appointment, the patient reported, she had not used the stimulation because it was not in the correct area.Reprogramming was able to provide stimulation to 50% of the pain area.The patient still felt a tingling in her hand and arm.At the last appointment the patient reported 20% stimulation coverage.The patient reported she still only had left pain relief.In addition, the patient reported the stimulation makes her left foot feel like it is dropping when the stimulation is turned on.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and 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
• Manufacturer (Section D): ST. JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer st. clair ; 6901 preston rd.; plano, TX 75024 ; 9725264677
• MDR Report Key: 3596392
• MDR Text Key: 4066546
• Report Number: 1627487-2014-04036
• 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: 12/30/2013

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: 3228
• Device Lot Number: 4191849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: SCS IPG: MODEL 3688; SCS EXTENSION: MODEL 3383 (2); IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 69 YR