St. Jude warns of bat­tery de­fect in some heart de­vices

Kuwait Times - - HEALTH & SCIENCE -

Med­i­cal de­vice maker St. Jude Med­i­cal is warn­ing doc­tors and pa­tients about a rare bat­tery de­fect in some of its im­plantable heart de­vices that can cause them to fail much ear­lier than ex­pected. The com­pany said Tues­day that two deaths have been linked to the prob­lem and 10 more pa­tients fainted be­cause the de­vices stopped work­ing.

St. Jude said the bat­ter­ies should be re­placed im­me­di­ately af­ter pa­tients re­ceive an elec­tronic, vi­brat­ing alert from the de­vice. Nor­mally pa­tients have up to three months to have bat­ter­ies re­placed. But the com­pany said a small sub­set of its heart-shock­ing defibrillators can fail within 24 hours of the alert. The prob­lem af­fects a sub­set of its For­tify, Quadra and Unify de­vices. Spe­cific model and se­rial num­bers are avail­able on St. Jude’s web­site.

The me­tal­lic im­plants are used to treat dan­ger­ous heart rhythms that can lead to car­diac ar­rest, heart fail­ure and death. The de­sign flaw is caused by buildup of de­posits around lithium bat­ter­ies that power the de­vices. St. Jude said it fixed the is­sue in May 2015 and re­moved all af­fected de­vices from dis­tri­bu­tion and hospi­tal in­ven­to­ries.

350,000 pa­tients af­fected

Nearly 350,000 pa­tients world­wide could have de­vices af­fected by the is­sue, ac­cord­ing to a sep­a­rate state­ment from the Food and Drug Ad­min­is­tra­tion. As in sim­i­lar cases, reg­u­la­tors are not rec­om­mend­ing that pa­tients with the de­vices have them pre­emp­tively re­moved. That’s be­cause the risks of the sur­gi­cal pro­ce­dure are gen­er­ally much higher than the po­ten­tial harms of the de­fect it­self.

St. Jude noted the ac­tu­ally preva­lence of the is­sue is very rare: “the vast ma­jor­ity of de­vices sold world­wide have not ex­pe­ri­enced pre­ma­ture bat­tery de­ple­tion.” Jef­feries an­a­lyst Raj Den­hoy es­ti­mated the ac­tual num­ber of de­vices af­fected by the prob­lem is likely 2,000 - at the most - based on prior es­ti­mates of lithium bat­tery de­posits pub­lished in the med­i­cal lit­er­a­ture. “It seems un­likely that St. Jude will ex­pe­ri­ence any pro­tracted im­pact to its market share,” Den­hoy said in a note to in­vestors.

All ma­jor man­u­fac­tur­ers of im­plantable heart defibrillators have re­ported mal­func­tions and re­calls, in­clud­ing com­peti­tors Medtronic Inc., Bos­ton Sci­en­tific and St. Jude it­self. In 2010, the St. Paul, Min­nesotabased com­pany stopped sell­ing defibrillators with cer­tain wires be­cause they could pre­ma­turely crack and fail. Last year the com­pany paid $14.5 mil­lion to set­tle hundreds of law­suits filed by cus­tomers who re­ceived de­vices with the wires.

Ear­lier this year Ab­bott Lab­o­ra­to­ries an­nounced it would acquire St. Jude for ap­prox­i­mately $25 bil­lion. Tues­day’s an­nounce­ment is not ex­pected to af­fect the deal. Shares of St. Jude Med­i­cal Inc. fell $2.87, or 3.5 per­cent, to close at $78.41. —AP

LIT­TLE CANADA, MINNESOTA: This Wed­nes­day, July 22, 2015, file photo shows St. Jude Med­i­cal cor­po­rate head­quar­ters. —AP

Newspapers in English

Newspapers from Kuwait

© PressReader. All rights reserved.