Brand Name | PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR |
Type of Device | SCS IPG |
Manufacturer (Section D) |
ABBOTT MEDICAL |
6901 preston rd |
plano TX 75024 |
|
Manufacturer (Section G) |
ABBOTT MEDICAL |
6901 preston rd |
|
plano TX 75024 |
|
Manufacturer Contact |
ronnie
shalev
|
6901 preston road |
plano, TX 75024
|
9723098000
|
|
MDR Report Key | 15222849 |
MDR Text Key | 297855801 |
Report Number | 1627487-2022-04420 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05415067020192 |
UDI-Public | 05415067020192 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial,Followup,Followup |
Report Date |
09/19/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/14/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/04/2019 |
Device Model Number | 3660 |
Device Catalogue Number | 3660 |
Device Lot Number | 5968017 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/12/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/04/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 1627487/06/02/2017/001-C |
Patient Sequence Number | 1 |
Treatment | SCS LEAD (X2); SCS LEAD ANCHOR (X2) |
Patient Outcome(s) |
Other;
|
Patient Age | 43 YR |
Patient Sex | Female |
Patient Weight | 54 KG |