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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 PERCUTANEOUS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problem Disconnection (1171)
Patient Problem Pain (1994)
Event Date 02/28/2020
Event Type  Injury  
Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information. The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer reference number: 1627487-2020-03572, 1627487-2020-03574. It was reported the patient experienced pain at the ipg site. X-rays confirmed the leads have pulled out of the ipg. Surgical intervention may take place at a later date.

 
Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.  .

 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DevicePERCUTANEOUS 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
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key9917792
MDR Text Key186199445
Report Number1627487-2020-03573
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2011
Device MODEL Number3186
Device Catalogue Number3186
Device LOT Number2879578
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/02/2020 Patient Sequence Number: 1
Treatment
MODEL 3186 LEAD; MODEL 3716 IPG
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