Brand Name | RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, EL |
Type of Device | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
parque industrial, zona franca coyol s.a. |
edificio #44b, calle 0, avenida 2, coyol |
alajuela, costa rica 1897- 4050 |
CS 1897-4050 |
|
MDR Report Key | 9590527 |
MDR Text Key | 175023592 |
Report Number | 3008452825-2020-00018 |
Device Sequence Number | 1 |
Product Code |
DRF
|
UDI-Device Identifier | 05414734200561 |
UDI-Public | 05414734200561 |
Combination Product (y/n) | N |
PMA/PMN Number | K894500 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
02/17/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2022 |
Device Model Number | 401227 |
Device Catalogue Number | 401227 |
Device Lot Number | 7212641 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/08/2020
|
Initial Date FDA Received | 01/15/2020 |
Supplement Dates Manufacturer Received | 01/24/2020
|
Supplement Dates FDA Received | 02/17/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ADVISOR¿ HD GRID MAPPING CATHETER, SE; BRK-1¿ XS TRANSSEPTAL NEEDLE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER; ADVISOR¿ HD GRID MAPPING CATHETER, SE; BRK-1¿ XS TRANSSEPTAL NEEDLE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER |
Patient Outcome(s) |
Death;
|
Patient Age | 69 YR |
Patient Weight | 48 |
|
|