REOCOR D

Additional Manufacturer Narrative

THE DEVICE(S) ARE CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN BASED ON AVAILABLE INFORMATION AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

Description of Event or Problem

BIOTRONIK RECEIVED EIGHT MEDWATCH REPORTS FROM THE FDA, EACH CONCERNING A REOCOR S/D DEVICE. ALL REPORTS CONTAINED IDENTICAL INFORMATION. ACCORDING TO THE REPORTS: THE EXTERNAL PACEMAKER DEVICE, SPECIFICALLY THE REOCOR (MANUFACTURER: BIOTRONIK; MODELS: REOCOR S, REOCOR D), UNEXPECTEDLY CEASED OPERATION DURING THE BATTERY REPLACEMENT PROCESS, LEADING TO THE PATIENT EXPERIENCING CARDIAC ARREST. THE ORIGINAL MANUFACTURERS MANUAL STATED THAT THERE IS A 30-SECOND WINDOW (DURING WHICH THE CIRCUIT BOARD MAINTAINS POWER/IS SUPPORTED BY RESIDUAL POWER) FOR BATTERY REPLACEMENT. HOWEVER, SEVEN UNITS OF THE EQUIPMENT ARE CURRENTLY IN A FAILURE/INOPERATIVE STATE. NO SERIAL NUMBERS WERE DISCLOSED. REF MEDWATCH REPORTS: MW5180093, MW5180094, MW5180095, MW5180096, MW5180097, MW5180098, MW5180099, MW5180100.