Brand Name | PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR |
Type of Device | SCS IPG |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer Contact |
ronnie
shalev
|
6901 preston road |
plano, TX 75024
|
9723098000
|
|
MDR Report Key | 14175679 |
MDR Text Key | 289857125 |
Report Number | 3006705815-2022-13856 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05415067031419 |
UDI-Public | 05415067031419 |
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 |
06/23/2022 |
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 | 12/10/2022 |
Device Model Number | 3660 |
Device Catalogue Number | 3660 |
Device Lot Number | A000104118 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/01/2022 |
Initial Date FDA Received | 04/21/2022 |
Supplement Dates Manufacturer Received | 05/12/2022 06/21/2022
|
Supplement Dates FDA Received | 06/07/2022 06/23/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/10/2020 |
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 ANCHOR (X2); SCS LEAD (X2) |
Patient Sex | Female |