Brand Name | ANTHEM RF CRT-P |
Type of Device | IMPLANTABLE PACEMAKER PULSE GENERATOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. (CRM-KISTA) |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC. (CRM-KISTA) |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
ulla
strindlund
|
box 7051 |
isafjordsgatan 15 |
kista SE-16-407
|
SW
SE-16407
|
4684744043
|
|
MDR Report Key | 5166798 |
MDR Text Key | 28937773 |
Report Number | 3010215456-2015-29525 |
Device Sequence Number | 1 |
Product Code |
NKE
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Report Date |
09/30/2015 |
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 |
Health Professional
|
Device Expiration Date | 03/31/2012 |
Device Model Number | PM3212 |
Device Lot Number | 3228020 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/21/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/30/2010 |
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 |