PROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR 3662

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 2020-03-31 for PROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR 3662 manufactured by St. Jude Medical - Neuromodulation (puerto Rico, Llc).

Event Text Entries

[185915745] The event date is unknown. The patient's weight was unable to be obtained. The results/method and conclusion codes along with the investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[185915746] It was reported the patient experienced an infection at their ipg site. In turn, the physician decided explant the patient's scs system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006705815-2020-01502
MDR Report Key9908177
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-01-14
Date Added to Maude2020-03-31
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 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 Details

Brand NamePROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR
Generic NameSCS IPG
Product CodeLGW
Date Received2020-03-31
Model Number3662
Catalog Number3662
Lot NumberA000072264
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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. Other 2020-03-31

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