LEAD DELIVERY SYS, 19CM (7.5 IN), 1 EACH 1773

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-24 for LEAD DELIVERY SYS, 19CM (7.5 IN), 1 EACH 1773 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[26686170] (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).
Patient Sequence No: 1, Text Type: N, H10


[26686171] Device 1 of 3. Reference mfr report #: 1627487-2015-07563 and 1627487-2015-07564. It was reported the patient underwent the permanent implant procedure on (b)(6) 2015. During the surgery, the physician was unable to access the epidural space with three epiducers due to the patient's anatomy. The patient was eventually implanted but the procedure was extended for 45 to 60 minutes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2015-07562
MDR Report Key5101420
Report SourceCOMPANY REPRESENTATIVE
Date Received2015-09-24
Date of Report2015-08-28
Date of Event2015-08-28
Date Mfgr Received2015-08-28
Device Manufacturer Date2015-04-23
Date Added to Maude2015-09-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer G1ST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Street6901 PRESTON RD
Manufacturer CityPLANO TX 75024
Manufacturer CountryUS
Manufacturer Postal Code75024
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEAD DELIVERY SYS, 19CM (7.5 IN), 1 EACH
Generic NameSCS EPIDUCER
Product CodeLHG
Date Received2015-09-24
Model Number1773
Lot Number5062579
Device Expiration Date2017-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Address6901 PRESTON RD PLANO TX 75024 US 75024


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-09-24

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