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This article was originally published in The Gray Sheet

Executive Summary

INTERMEDICS' INTERTACH II PACER FOR EXTERNAL USE NEEDS PMA SUPPLEMENT approval, FDA says in a March 10 warning letter to the firm. FDA charges that the Intertach II model 262-16 pacemaker "is that it is being commercially distributed for a new intended use and...does not have an approved supplement" in effect. Currently, the Intertach II is approved for internal use only. According to FDA's letter, the Intertach II also is misbranded, in that "the labeling fails to bear adequate directions for use, because adequate directions cannot be written for an unapproved use of the device." FDA further cites Intermedics' failure to maintain a device master record for the Intertach II pacemaker for external use. The warning letter, based on a Jan. 4-26 inspection of the firm's Angleton, Texas manufacturing facility, also cites the firm for several good manufacturing practice violations. The company responded to the warning letter on April 1. Among the cited deficiencies are that the company did not "adequately investigate, after a device [had] been released for distribution, any failure of that meet performance specifications and to maintain a written record of the investigation." For example, the agency notes that a failure investigation into an Intertach II complaint filed in April 1991, "concerning absence of telemetry transmission," was incomplete, as it "did not include a conclusion and follow-up." The agency additionally charges that the company failed to assure that all quality assurance checks are "appropriate and are performed correctly." Specifically, FDA notes that Intermedics' COSMOS II pacemaker "passed its final device electrical test even though the test lead wires were incorrectly installed." The warning letter also points out Intermedics' failure to investigate a "critical device or component" that does not meet its performance specifications and the company's failure to submit "a written record of the investigation, including conclusions and follow-up." FDA cites as an example that "over 200" reprocessing events for certain chip capacitors have occurred without any investigations "into these failures to meet product specifications."

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