INNOSPIRE MINI

Additional Manufacturer Narrative

THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION ALLEGING THAT A PATIENT WITH AN INNOSPIRE MINI DEVICE HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE FAMILY MEMBER INQUIRED WHETHER THE DEVICE COULD BE RETURNED AND USED BY SOMEONE ELSE. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. MULTIPLE GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, WITHOUT CUSTOMER RESPONSE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

Description of Event or Problem

THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PATIENT WITH AN INNOSPIRE MINI DEVICE HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE FAMILY MEMBER INQUIRED WHETHER THE DEVICE COULD BE RETURNED AND USED BY SOMEONE ELSE. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.