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 |
|
MDR Report Key | 11662249 |
MDR Text Key | 245342827 |
Report Number | 3006705815-2021-01699 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05415067020192 |
UDI-Public | 05415067020192 |
Combination Product (y/n) | N |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Type of Report
| Initial,Followup |
Report Date |
05/19/2021 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/05/2020 |
Device Model Number | 3660 |
Device Catalogue Number | 3660 |
Device Lot Number | A000060144 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/09/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/26/2021 |
Initial Date FDA Received | 04/13/2021 |
Supplement Dates Manufacturer Received | 05/18/2021
|
Supplement Dates FDA Received | 05/19/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 42 YR |
|
|