Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
- Company
- Ela Medical Llc
- Recall Initiated
- October 25, 2005
- Posted
- December 2, 2005
- Terminated
- January 28, 2007
- Recall Number
- Z-0266-06
- Quantity
- 17
- Firm Location
- Plymouth, MN
Reason for Recall
Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.
Distribution
Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
Lot / Code Info
Symphony DR 2250 serial numbers: 238WG020, 243WG055, 246WG094, 246WG109, 250WG029, 303WG027, 303WG038, 303WG074, 303WG078, 306WG073, 309WG262, 314WG057, 315WG188 and 320WG220. Rhapsody DR 2510 Serial numbers: 318WJ010, 318WJ060 and 318WJ061
Root Cause
Other
Action Taken
A Dear Doctor letter, dated 10/25/05, was sent to all affected doctors. The letter describes the failures and mentions that pacemaker depend patients implanted with devices manufactured in the first group could require prophylactic replacement.