In short
Inevitably it’s hotting up still further. In an effort to defend its corner in the ICD Lead problem debacle, St. Jude Medical, Inc. has come out fighting by posting information from the MAUDE database showing 377 deaths associated with the Medtronic Quattro Secure lead, rather than the 62 that was reported by Dr. Robert Hauser in a manuscript published online last week by the Heart Rhythm Journal.
Background
Over the weekend St. Jude very publicly took issue with the conclusions presented in Dr Robert Hauser’s paper which has been accepted for publication by the journal Heart Rhythm. If you remember, the source was FDA’s own MAUDE database, from which Dr Hauser had concluded that 62 deaths in the Medtronic Quattro Secure group were attributable to lead failure. St. Jude’s position was (and probably remains) that following its own analysis this number should have been 377 if it were to match the criteria used in analysis of its own leads and after errors such as duplicates, inconsistent categorisations and failure to include all reports.
In a press release issued yesterday (April 10th) St. Jude states that “Dr. Hauser’s review of the number of deaths in the MAUDE database was wrong by greater than a factor of six.
Furthermore, it has helpfully provided information on all 377 reports for the Medtronic Quattro Secure lead on its Riatacommunication.com website, here. We’ve trawled through the reports and fascinating, if distressing, reading they make. While it’s questionable whether the lead was implicated in any or all of the deaths, there don’t appear to be many where it can be completely ruled out. But whether it can or cannot be ruled out is less the issue than whether the same rules applied to Riata and Riata ST patients, whether at the reporting or data analysis level.
St. Jude clearly believes deaths that were questionable (in terms of being lead-related) were included in analysis of Riata (and ST), and not in Quattro Secure.
The press release wraps up with a direct invitation to Dr Hauser to “state specifically whether or not he stands behind the factual accuracy of the number 62 used in comparing the St. Jude Medical Riata® and Riata ST leads to the Medtronic Quattro Secure device”.
The company also invites Medtronic to review the MAUDE database report findings.
Source: St Jude Medical Inc., Business Wire
published: April 11, 2012 in: Alerts/Adverse Events, Cardio, Clinical Studies/Trials, Journals, Medtronic, St Jude