PENA MUSCLE STIMULATOR PROBE (NOT STERILE) PS-2P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-02-24 for PENA MUSCLE STIMULATOR PROBE (NOT STERILE) PS-2P manufactured by Integra Neurosciences Implants S.a..

Event Text Entries

[17578439] The third report of eight from the same facility involving pena probe. Cross reference with mfr. Report 9612007-2014-00003. A report was received from a children's hospital that the pena probe stopped/didn't work. The consultant surgeon cut the cable and exposed the inner cabling which appeared to be oxidized. The probe was in contact with a patient (age of the patient is not available). There was a delay while the staff located another probe to use. There was no injury involved as a result of the delay.
Patient Sequence No: 1, Text Type: D, B5


[17787319] The device involved in the reported incident has been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612007-2014-00010
MDR Report Key3902047
Report Source01,05
Date Received2014-02-24
Date of Report2014-01-29
Date Mfgr Received2014-01-29
Date Added to Maude2014-07-15
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 FDA0
Event Location0
Manufacturer ContactLINDA SERENTINO
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer Phone6099365560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENA MUSCLE STIMULATOR PROBE (NOT STERILE)
Generic NamePENA MUSCLE STIMULATOR PROBE
Product CodeIPF
Date Received2014-02-24
Catalog NumberPS-2P
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA NEUROSCIENCES IMPLANTS S.A.
Manufacturer AddressSOPHIA ANTIPOLIS F-06921 FR F-06921


Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-24

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