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HRD-84-33 1 (1984-04-16)

handle is hein.gao/gaobabnih0001 and id is 1 raw text is: UNITED STATES GENERAL ACCOUNTING OFFICE WASHINGTON. D.C. 20548 HUMAN RESOURCES DIVISION APRIL 16, 1984- B-214802 The Honorable Harry 14. Walters Administrator of Veterans Affairs 123920 Dear Mr. Walters: Subject: VA Central Office Needs to Exercise Better Oversight of Cardiac Pacemaker Recalls (GAO/HRD-84-33) This report summarizes the results of our review of Vet- erans Administration (VA) actions taken in response to recalls of defective pacemakers. hrile VA medical centers receive no- tification of recalls from several sources, stronger central office oversight is needed to insure that (1) patients are informed of pacemaker recalls or the reasons for not informing them are documented in their medical records and (2) actions taken in response to recalls are in accordance with central of- fice guidance and documented in the patients' medical records. BACKGROUND A cardiac pacemaker is an internal or external electronic device used to regulate the action of the heart. An external pacemaker remains outside the body, and its use is temporary until the patient's heart rhythm stabilizes or until a permanent pacemaker is implanted. An internal pacemaker is one in which the pulse generator is implanted permanently under the skin with the electrical leads guided to the heart. According to VA's Program Chief, Cardiovascular Diseases, a patient is considered pacemaker dependent if the pacemaker is necessary for maintaining the patient's life and nondependent if the pacemaker is used to make the patient feel better but is not necessary for maintaining life. He said that a nondependent patient may experience such symptoms as fainting or palpitations without a pacemaker. GI'S 1 (401933)

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