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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DualChamber External Temporary Pulse Generators Model 5388

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  Class 2 Device Recall Medtronic DualChamber External Temporary Pulse Generators Model 5388 see related information
Date Initiated by Firm October 11, 2010
Date Posting Updated November 22, 2010
Recall Status1 Terminated 3 on May 29, 2012
Recall Number Z-0430-2011
Recall Event ID 57098
PMA Number P820003S072 
Product Classification Implantable pulse generator, pacemaker (non-crt) - Product Code LWP
Product Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.
Code Information PFG053456P, PFG053457P, PFG053458P, PFG053459P, PFG053460P, PFG053461P, PFG053462P, PFG053464P thru PFG053485P, PFG053487P, PFG053488P, PFG053489P, PFG053490P, PFG053492P thru PFG053538P, PFG053540P thru PFG053570P, PFG053572P thru PFG053597P, PFG053600P, PFG053602P, PFG053603P, PFG053604P, PFG053605P, PFG053606P, PFG053607P, PFG053608P, PFG053609P, PFG053610P, PFG053612P, PFG053613P, PFG053614P, PFG053617P thru PFG053697P, PFG100003R, PFG100004R, PFG100005R, PFG100006R, PFG100008R, PFG100009R, PFG100011R, PFG100013R, PFG100014R, PFG100015R, PFG100016R, PFG100018R, PFG100020R, PFG100021R, PFG100022R, PFG100023R, PFG100024R, PFG100025R, PFG100027R, PFG100030R, PFG100031R, PFG100032R, PFG100033R, PFG100034R, PFG100035R, PFG100036R, PFG100037R, PFG100038R, PFG100039R, PFG100041R, PFG100043R, PFG100044R, PFG100045R, PFG100046R, PFG100047R, PFG100048R, PFG100049R, PFG100050R, PFG100051R, PFG100052R, PFG100053R, PFG100054R, PFG100056R, PFG100057R, PFG100058R, PFG100059R, PFG100060R, PFG100061R, PFG100062R, PFG100064R, PFG100066R, PFG100067R, PFG100068R, PFG100069R, PFG100070R, PFG100071R, PFG100072R, PFG100073R, PFG100075R, PFG100077R, PFG100078R, PFG100079R, PFG100080R, PFG100081R, PFG100082R, PFG100083R, PFG100084R, PFG100085R, PFG100087R, PFG100089R, PFG100091R, PFG100092R, PFG100093R, PFG100094R, PFG100097R, PFG100098R, PFG100099R, PFG100100R, PFG100101R, PFG100102R, PFG100103R, PFG100104R, PFG100106R, PFG100108R, PFG100109R, PFG100110R, PFG100111R, PFG100112R, PFG100113R, PFG100114R, PFG100115R, PFG100116R, PFG100117R, PFG100118R, PFG100119R, PFG100120R, PFG100122R, PFG100123R, PFG100124R, PFG100125R, PFG100127R, PFG100128R, PFG100130R, PFG100132R, PFG100133R, PFG100135R, PFG100136R, PFG100137R, PFG100138R, PFG100139R, PFG100140R, PFG100141R, PFG100142R, PFG100144R thru PFG100259R, PFG100261R, PFG100262R, PFG100263R, PFG100265R, PFG100266R, PFG100268R thru PFG100327R, PFG100329R, PFG100330R, PFG100331R, PFG100332R, PFG100334R thru PFG100367R, PFG100369R, PFG100370R, PFG100371R, PFG100372R, PFG100373R, PFG100374R, PFG100375R, PFG100377R, PFG100378R, PFG100379R, PFG100380R, PFG100381R, PFG100382R, PFG100384R thru PFG100410R, PFG100412R, PFG100413R, PFG100414R, PFG100415R, PFG100416R, PFG100417R, PFG100418R, PFG100421R, PFG100422R, PFG100424R, PFG100425R, PFG100426R, PFG100428R, PFG100429R, PFG100430R, PFG100432R, PFG100433R, PFG100434R, PFG100435R, PFG100436R, PFG100437R, PFG100438R, PFG100439R, PFG100440R, PFG100441R, PFG100442R, PFG100444R thru PFG100490R, PFG100492R thru PFG100511R, PFG100513R, PFG100514R, PFG100515R, PFG100516R, PFG100517R, PFG100518R, PFG100519R, PFG100520R, PFG100521R, PFG100522R, PFG100523R, PFG100524R, PFG100525R, PFG100526R, PFG100527R, PFG100529R, PFG100531R thru PFG100588R, PFG100590R thru PFG100625R, PFG100627R thru PFG100676R, PFG100678R, PFG100679R, PFG100680R thru PFG100807R, PFG100809R, PFG100810R, PFG100811R, PFG100812R, PFG100813R, PFG100814R, PFG100816R, PFG100817R, PFG100818R, PFG100819R, PFG100820R, PFG100821R, PFG100823R thru PFG100844R, PFG100847R thru PFG100871R, PFG100873R thru PFG100890R, PFG100892R, PFG100893R, PFG100895R, PFG100896R, PFG100897R, PFG100898R, PFG100899R, PFG100900R, PFG100901R thru PFG101019R, PFG101022R, PFG101024R thru PFG101058R, PFG101061R, PFG101062R, PFG101063R, PFG101064R, PFG101065R, PFG101066R, PFG101067R, PFG101068R, PFG101069R, PFG101070R, PFG101071R, PFG101072R, PFG101074R, PFG101076R, PFG101077R, PFG101080R, PFG101081R, PFG101082R, PFG101083R, PFG101084R, PFG101085R, PFG101086R, PFG101087R, PFG101088R, PFG101089R, PFG101090R, PFG101091R, PFG101093R, PFG101095R, PFG101096R, PFG101098R, PFG101101R thru PFG101182R, PFG101184R, PFG101185R, PFG101186R, PFG101187R, PFG101188R, PFG101189R, PFG101190R, PFG101191R, PFG101192R, PFG101193R, PFG101194R, PFG101195R, PFG101196R, PFG101197R, PFG101198R, PFG101199R, PFG101201R, PFG101202R, PFG101203R, PFG101204R, PFG101205R, PFG101207R thru PFG101241R, PFG101243R, PFG101245R thru PFG101292R, PFG101294R thru PFG101305R, PFG1
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact Instruments Technical Service
800-638-1991
Manufacturer Reason
for Recall
A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Medtronic issued an Important Medical Device Correction letters, dated October 2010 and November 2010 to hospital's biomedical engineering department. The letter described the issue, how it presents, and stated that Medtronic will contact the hospitals to return affected product for servicing. The second letter reiterated that Medtronic would notify customers when FDA approves their design upgrade for returning devices for service. In the interim, hospitals should continue to use normally functioning devices. Cusotmers may contact Medtronic Instruments Technical Service at 800-638-1991 concerning this action.
Quantity in Commerce 5,595 ( 2,696 US, 2,899 OUS) EXPANDED: 944 (852 US, 92 OUS)
Distribution Worldwide Distribution: throughout USA and territories of Guam and Puerto Rico and to the countries of: Algeria, Argentina, Australia, Austria, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Guiana, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen NO ADDITIONAL COUNTRIES ARE AFFECTED BY THE EXPANSION.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWP and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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