Model Number ENO DR |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/27/2021 |
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 microport crm that was cleared or approved by fda for marketing in the united states.
|
|
Event Description
|
Reportedly, when scanning the barcode on the box of the subject pacemaker, the tracking software of the center did not trace the correct serial number of the subject device; the serial number of an already implanted device was displayed.
|
|
Event Description
|
Reportedly, when scanning the barcode on the box of the subject pacemaker, the tracking software of the center did not trace the correct serial number of the subject device; the serial number of an already implanted device was displayed.
|
|
Manufacturer Narrative
|
E1 corrected.Please refer to the attached analysis report.
|
|
Search Alerts/Recalls
|