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

Model Number 3228

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Convulsion, Clonic (2222); Inadequate Pain Relief (2388)

Event Date 09/03/2013

Event Type  Injury  

Event Description

It was reported the pt is experiencing muscle spasms.In addition, the pt reported the ipg is not working as desired.Follow up identified that reprogramming could not be attempted as the ipg hadn't been charged.Pt education regrading charging was provided.The pt has expressed a desire to have her scs system explanted, stating when stimulation is on, she has convulsions.Surgical intervention will be undertaken at a later date to resolve the reported issue.

Manufacturer Narrative

Sjm has limited info 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: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3850354
• MDR Text Key: 4412066
• Report Number: 1627487-2014-26402
• 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: 04/23/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 3228
• Device Lot Number: 3517929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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: SCS IPG: MODEL 3788; IMPLANTED:
• Patient Outcome(s): Other
• Patient Age: 75 YR