OCTRODE LEAD KIT, 60CM LENGTH 3186

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-19 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St. Jude Medical - Neuromodulation (puerto Rico, Llc).

Event Text Entries

[130972862] Device 1 of 3. Reference mfr. Report#: 3006705815-2018-03386 and 3006705815-2018-03390. It was reported the patient? S entire scs system was removed due to an infection. The site of the infection was ipg and lead site. Postoperatively, the patient has antibiotic therapy.
Patient Sequence No: 1, Text Type: D, B5


[133908207] Device 1 of 3. Reference mfr. Report#: 3006705815-2018-03386 and 3006705815-2018-03390. Further follow-up indicates the patient's infection has resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006705815-2018-03389
MDR Report Key8182877
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-19
Date of Report2019-01-23
Date of Event2018-09-12
Date Mfgr Received2019-01-07
Device Manufacturer Date2018-07-19
Date Added to Maude2018-12-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANDREA DEITZ
Manufacturer Street6901 PRESTON ROAD
Manufacturer CityPLANO TX 75024
Manufacturer CountryUS
Manufacturer Postal75024
Manufacturer Phone9723098000
Manufacturer G1ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
Manufacturer StreetLOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK
Manufacturer CityARECIBO PR 00612
Manufacturer CountryUS
Manufacturer Postal Code00612
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Generic NameSCS LEAD
Product CodeLGW
Date Received2018-12-19
Returned To Mfg2018-12-13
Model Number3186
Lot NumberA000062066
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
Manufacturer AddressLOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK ARECIBO PR 00612 US 00612

Device Sequence Number: 1

Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Generic NameSCS LEAD
Product CodeLSW
Date Received2018-12-19
Returned To Mfg2018-12-13
Model Number3186
Lot NumberA000062066
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
Manufacturer AddressLOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK ARECIBO PR 00612 US 00612


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2018-12-19

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