Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
This recall has been terminated (originally issued January 11, 2012).
- Company
- St Jude Medical Crmd
- Recall Initiated
- September 23, 2011
- Posted
- January 11, 2012
- Terminated
- April 10, 2012
- Recall Number
- Z-0430-2012
- Quantity
- 14,000 units
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
Reason for Recall
St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
Distribution
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.
Lot / Code Info
Models PM3110, 3112, 3210,3212 (Anthem) and All lots and serial numbers
Root Cause
Pending
Action Taken
The firm, St. Jude Medical, sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer. Customers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.