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

Model Number 3225

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Inadequate Pain Relief (2388)

Event Date 12/26/2013

Event Type  Injury  

Event Description

It was reported the patient experienced difficulty increasing stimulation.It was also reported the patient experienced muscle spasm when stimulation was on a high setting.Follow-up revealed the patient recently lost stimulation after falling.An impedance check was performed and several invalid contacts were found.Reprogramming to provide resolution was unsuccessful.As a result, the patient plans to undergo surgical intervention.

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.

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.

Event Description

Follow-up revealed the patient's lead was explanted and replaced.It was also reported, the doctor electively explanted and replaced the patient's ipg (with a different model).

• Brand Name: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4085059
• MDR Text Key: 4894085
• Report Number: 1627487-2014-05619
• 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,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/20/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2013
• Device Model Number: 3225
• Device Lot Number: 3456416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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: IMPLANT:
• Patient Outcome(s): Other
• Patient Age: 44 YR