Tag: Safety Advisory

Class 1 Recall Issued for Boston Scientific S-ICD Lead

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Patients with a Boston Scientific S-ICD should be aware of a Class I recall of the 3501 Emblem subcutaneous electrode.  This model was manufactured from March 2016 through November 2020.
 
 
This same issue was the subject of a product advisory issued in December of 2020, but due to 26 serious injuries and one death associated with the device, the advisory was upgraded to a recall.   
 
 
Boston Scientific has a product lookup tool (www.BostonScientific.com/lookup) where you can look up your device and see if your specific lead is affected.  You can find your serial numbers on your registration card.
 
 
You can read the HCMBeat’s previous entry on this issue here. 
 

Medtronic ICD Advisory Expanded

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The January recall of 48 Medtronic CRT-D and ICDs has now been expanded to include 752 additional devices at lower risk than those involved in the January recall,.  There is an issue that occurred during the manufacturing process of these devices which could result in an unexpected loss of device functionality.  If you have one of these devices, you should contact your doctor to discuss next steps.

You can see the advisory here.

To look up your device by product name, model or serial number to see whether it is impacted, click here.

The box in the upper right corner labeled “Advisories For This Model” will tell you if there are any advisories for your device.

If you are affected, the search page would look like this:

Hugo MDT

This example shows that currently there are no advisories for my model.

Protecta MDT page

As always, you can call Medtronic Patient Services with any questions at: (800) 551-5544 (M – F, 8am – 5pm Central)

 

 

Could St. Jude ICDs be a Target for Hackers? FDA Issues Safety Advisory

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The U.S. Food and Drug Administration today issued a safety advisory regarding St. Jude Medical implantable cardiac devices used in conjunction with St. Jude’s proprietary Merlin @home Transmitter.

According to the advisory, these devices could potentially be vulnerable to hacking. However, only a highly skilled hacker would be sophisticated enough to exploit the vulnerability.  Such unwarranted interference could conceivably cause premature battery depletion or unnecessary shocks.

A software patch has been developed for the Merlin @home monitor designed to address the issue and to reduce the risk of hacking.  The update is now available and will be applied automatically to the Merlin monitor.

***Patients only need to make sure their Merlin@home Transmitter remains plugged in and connected in order to receive the software patch.***

Short-selling firm Muddy Waters first went public with this information in August, believing that it might cause a pending $25 billion acquisition of St. Jude Medical by Abbott Laboratories to fall apart. However, the deal closed last week despite the issue.

See also:

This article on Medscape

This article in the Minneapolis Star Tribune.

This article on Huffington Post.

This article on CNBC.