N
Patient 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 6506494
- MDR report key
- 6506494
- Report number
- 8044004-2017-05002
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-03-22
- Date received
- 2017-04-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- SHARON MURPHY
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MICROSTREAM | ORIDION MEDICAL | MNR | CS08651-02 | CS08651-02 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-19 | 0 |
Event Narratives#
D
Patient 1
MEDTRONIC RECEIVED A REPORT THAT THE UNIT DID NOT GENERATE AN AUDIBLE ALARM. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.
N
Patient 1
THE SAMPLE ASSOCIATED TO THIS REPORT WAS RECEIVED AND THE CUSTOMER REPORTED ISSUE COULD NOT BE DUPLICATED.? WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO DETECT DAMAGE AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
MEDTRONIC RECEIVED A REPORT THAT THE UNIT WAS NOT ALARMING, THEY HAD NO AUDIO. CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.