St. Jude Medical recalls Proclaim DRG Implantable Pulse Generator model 3664 due to error messages during impedance checks and transient overstimulation causing patient discomfort. Affected units have specific lot and serial numbers.
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
St. Jude Medical is recalling Proclaim DRG Implantable Pulse Generator model 3664 because some users reported error messages during routine impedance checks and temporary overstimulation causing discomfort. This recall affects specific units with listed lot and serial numbers.
The device may show error messages during routine impedance checks and cause temporary overstimulation, which leads to patient discomfort. This issue does not involve physical harm or serious injury but rather causes temporary discomfort.
People with the Proclaim DRG Implantable Pulse Generator model 3664 implant are affected. Those who have the specific lot and serial numbers listed in the recall are most at risk.
Check your Proclaim DRG Implantable Pulse Generator model 3664 for the lot numbers and serial numbers listed in the recall notice. The affected units have specific lot numbers and serial numbers provided in the recall.
Look for the lot number and serial number on your Proclaim DRG Implantable Pulse Generator model 3664 to see if it matches the affected units listed in the recall.
St. Jude Medical received complaints of error messages during routine impedance checks and transient overstimulation causing patient discomfort.
Check your device's lot number and serial number against the list provided in the recall notice to see if it is affected.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send St. Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1170-2018 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1170-2018 from St. Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
