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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD Back to Search Results
Model Number 3228
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Weakness (2145); Electric Shock (2554)
Event Date 11/25/2015
Event Type  Injury  
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.(b)(4).
 
Event Description
It was reported the patient experienced bilateral leg numbness and had difficulty walking after the permanent implant procedure.As a result, the patient has been using a wheelchair.The patient was hospitalized for two days due to the symptoms.Per the physician, the symptoms appeared to be unrelated to the scs system.As of 12/16/2015, the patient's symptoms were improving and the patient has been sent for rehabilitation.
 
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 identified the patient's weakness was still present, however, it was reportedly improving.Further information was received indicating surgical intervention is planned as the next course of action.
 
Event Description
Follow-up identified the patient experienced ineffective stimulation in addition to overstimulation in the back and hips.The patient stated having had a fall on (b)(6) 2015, however, the overstimulation was felt prior to the fall and occurred randomly during and prior to programming the scs system.The patient also stated that overstimulation felt like muscle spasms.Subsequently, surgical intervention was undertaken to explant the entire system.
 
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Brand Name
PENTA 3MM LEAD, 60 CM
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key5325003
MDR Text Key34291375
Report Number1627487-2015-21354
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2017
Device Model Number3228
Device Lot Number5118722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received03/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age53 YR
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