Brand Name | MAESTRO RECHARGEABLE SYSTEM |
Type of Device | POSTERIOR LEAD |
Manufacturer (Section D) |
ENTEROMEDICS, INC. |
2800 patton road |
saint paul MN 55113 |
|
Manufacturer (Section G) |
ENTEROMEDICS, INC. |
2800 patton road |
|
saint paul MN 55113 |
|
Manufacturer Contact |
katherine
tweden
|
2800 patton road |
saint paul, MN 55113
|
6516343209
|
|
MDR Report Key | 6262399 |
MDR Text Key | 65218679 |
Report Number | 3005025697-2017-00003 |
Device Sequence Number | 1 |
Product Code |
PIM
|
UDI-Device Identifier | 00857334004293 |
UDI-Public | 00857334004293 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P130019 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,s |
Reporter Occupation |
Physical Therapist
|
Type of Report
| Initial |
Report Date |
01/18/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 07/01/2014 |
Device Model Number | 2200P-47E |
Device Catalogue Number | 2200P-47E |
Device Lot Number | C4-08020 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/12/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/12/2015
|
Initial Date FDA Received | 01/18/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/11/2011 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | BECOLIDE PUFFER 1 PUFF; BIAXIG 300 MG; ESOMEPRAZOLE MAGNESIUM 40 MG; PARACETAMOL 1000 MG; RABEPRAZOLE20 MG; SIMVASTATIN 20 MG; VENTOLIN PUFFER 1 PUFF |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 62 YR |
Patient Weight | 94 |