PROCLAIM 5 ELITE 3660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-12-13 for PROCLAIM 5 ELITE 3660 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[130309877] It was reported that the patient had been receiving ineffective stimulation since falling on an unreported date. Reprogramming attempts were unsuccessful. X-rays were unremarkable for lead migration. As a result, the patient? S ipg was explanted and replaced on (b)(6) 2018. Therapy was restored post-op.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2018-13042
MDR Report Key8162487
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2018-12-13
Date of Report2018-12-13
Date of Event2017-12-01
Date Mfgr Received2018-11-26
Device Manufacturer Date2017-07-05
Date Added to Maude2018-12-13
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
Manufacturer Street6901 PRESTON RD
Manufacturer CityPLANO TX 75024
Manufacturer CountryUS
Manufacturer Postal Code75024
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NamePROCLAIM 5 ELITE
Generic NameSCS IPG
Product CodeLGW
Date Received2018-12-13
Model Number3660
Lot Number6046524
Device Expiration Date2019-07-05
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Address6901 PRESTON RD PLANO TX 75024 US 75024

Device Sequence Number: 1

Brand NamePROCLAIM 5 ELITE
Generic NameSCS IPG
Product CodeLSW
Date Received2018-12-13
Model Number3660
Lot Number6046524
Device Expiration Date2019-07-05
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 2018-12-13

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