Brand Name | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM |
Type of Device | DACAPO POWERPACK (TEMPO ACCU WYON) |
Manufacturer (Section D) |
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
innsbruck, tirol |
AU |
|
Manufacturer Contact |
laura
simonotti
|
fuerstenweg 77a |
innsbruck, tirol A-602-0
|
AU
A-6020
|
6460705562
|
|
MDR Report Key | 4662182 |
MDR Text Key | 15316849 |
Report Number | 9710014-2015-00238 |
Device Sequence Number | 1 |
Product Code |
MCM
|
Combination Product (y/n) | N |
PMA/PMN Number | P000025 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/27/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/01/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Lot Number | 0908I075 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 03/20/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 03/20/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 14 YR |
|
|