Brand Name | ACUITY X4 SPIRAL S |
Type of Device | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue north |
saint paul MN 55112 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
road 698, lot no. 12 |
|
dorado PR 00646 -260 |
*
00646-2602
|
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 14880720 |
MDR Text Key | 295117073 |
Report Number | 2124215-2022-23724 |
Device Sequence Number | 1 |
Product Code |
LWP
|
UDI-Device Identifier | 00802526524578 |
UDI-Public | 00802526524578 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | P010012/S398 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/30/2022 |
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 |
Lay User/Patient
|
Device Expiration Date | 04/27/2022 |
Device Model Number | 4675 |
Device Catalogue Number | 4675 |
Device Lot Number | 811546 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/16/2022 |
Initial Date FDA Received | 06/30/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/27/2020 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 81 YR |
Patient Sex | Male |