ATTAIN OVER THE WIRE LEAD 419378

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 2020-03-27 for ATTAIN OVER THE WIRE LEAD 419378 manufactured by Mpri.

Event Text Entries

[185224034] Product event summary: the partial lead was returned in segments, analyzed. Analysis indicated the distal conductor of the lead developed a fracture due to flexing while in vivo. Concomitant medical products: 6949, lead, implanted: (b)(6) 2004. 4269, lead, implant: (b)(6) 1993. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185224035] It was reported that there was no alleged product issue with the left ventricular (lv) lead as it was explanted when the patient underwent open heart surgery. The lv lead was returned to the manufacturer, analyzed, and subsequently tested out of specification.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2649622-2020-06386
MDR Report Key9888101
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-01-10
Date Mfgr Received2020-03-24
Device Manufacturer Date2004-03-31
Date Added to Maude2020-03-27
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 OVER THE WIRE LEAD
Generic NamePULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Product CodeLWP
Date Received2020-03-27
Returned To Mfg2020-03-16
Model Number419378
Catalog Number419378
Device Expiration Date2006-03-31
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMPRI
Manufacturer AddressROAD 149 KM 56.3 VILLALBA PR 00766 US 00766


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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