ATTAIN STABILITY QUAD MRI SURESCAN 479888

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 ATTAIN STABILITY QUAD MRI SURESCAN 479888 manufactured by Mpri.

Event Text Entries

[186120573] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186120594] It was reported a pocket revision was performed approximately three weeks post implant of the cardiac resynchronization therapy defibrillator (crt-d) system as the device site wound was not healing. Approximately three weeks after pocket revision, when the patient was seen in clinic, the site bandage was removed and the device was visible through a hole in the incision. The device system was explanted due to infection and the patient was treated with antibiotics. It was further reported that during interrogation of the device for extraction, the left ventricular (lv) lead was reported to have high thresholds. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[186865564] Product event summary: the full lead was returned and analyzed. No anomalies were found. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2649622-2020-06697
MDR Report Key9903728
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-16
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-08-26
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MPRI
Manufacturer StreetROAD 149 KM 56.3
Manufacturer CityVILLALBA PR 00766
Manufacturer CountryUS
Manufacturer Postal Code00766
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATTAIN STABILITY QUAD MRI SURESCAN
Generic NameDRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Product CodeOJX
Date Received2020-03-31
Returned To Mfg2020-03-27
Model Number479888
Catalog Number479888
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMPRI
Manufacturer AddressROAD 149 KM 56.3 VILLALBA PR 00766 US 00766


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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