MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
|
Back to Search Results |
|
Model Number PLATINIUM 4LV SONR CRT-D 1844 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
|
Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/14/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
|
|
Event Description
|
On (b)(6) 2017, the defibrillation system was implanted.Reportedly, during a follow-up on (b)(6) 2020, a shock therapy was observed on (b)(6) 2020.According to the physician, the shock is suspected to be inappropriate, as the patient was in an atrial fibrillation during almost the whole day.The clinical record of the patient was reviewed because vvi mode at 40 min-1 was programmed for an unknown reason.Reportedly the patient¿s condition worsened after the implantation, with a qrs length of 158 ms, which was longer with pacing than without pacing.It was also observed that no markers were recorded in the device memories for the shock nor for the atp therapy.Only the markers for the charges were observed.
|
|
Event Description
|
On (b)(6) 2017, the defibrillation system was implanted.Reportedly, during a follow-up on (b)(6) 2020, a shock therapy was observed on (b)(6) 2020.According to the physician, the shock is suspected to be inappropriate, as the patient was in an atrial fibrillation during almost the whole day.The clinical record of the patient was reviewed because vvi mode at 40 min-1 was programmed for an unknown reason.Reportedly the patient's condition worsened after the implantation, with a qrs length of 158 ms, which was longer with pacing than without pacing.It was also observed that no markers were recorded in the device memories for the shock nor for the atp therapy.Only the markers for the charges were observed.
|
|
Search Alerts/Recalls
|
|
|