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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3186
Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)
Patient Problems Device Overstimulation of Tissue (1991); Discomfort (2330); Inadequate Pain Relief (2388)
Event Date 06/23/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).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
Device 1 of 2: reference mfr.Report#: 1627487-2015-05454.It was reported the patient has been experiencing stimulation turning on and off by itself, overstimulation, and uncomfortable stimulation.Reprogramming and troubleshooting to address the issues have been unsuccessful.X-rays were taken and revealed no anomalies.In turn, the patient may undergo surgical intervention.
 
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
Device 1 of 2.Reference mfr.Report#: 1627487-2015-05454.Follow-up revealed the patient's scs system was explanted.
 
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
Device 1 of 2.Reference mfr.Report#: 1627487-2015-05454.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
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 Key5058917
MDR Text Key25099106
Report Number1627487-2015-05453
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Followup,Followup
Report Date 11/30/2015
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? Yes
Device Operator Health Professional
Device Expiration Date04/28/2012
Device Model Number3186
Device Lot Number3101623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/04/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received10/30/2015
12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2010
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) Other;
Patient Age75 YR
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