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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problems Fracture (1260); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/21/2019
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 3006705815-2019-05120.It was reported the patient experienced a fall and as a result the patient lost effective therapy.System diagnostics indicated both of the patient's leads were fractured.Additionally, all contacts had high impedance.As a result, the patient underwent surgical intervention wherein both leads were explanted and replaced.Effective therapy was established post operatively.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
PERCUTANEOUS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key9533753
MDR Text Key173281744
Report Number3006705815-2019-05121
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067017246
UDI-Public05415067017246
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,consum
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/02/2020
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 Expiration Date10/17/2020
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000068038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received02/17/2020
Supplement Dates FDA Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2018
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 Age36 YR
Patient Weight75
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