FDA Adverse Event
Injury
Summary report: N
MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD
MDR report key: 18955171
·
Received March 21, 2024
Report
- Report Number
- 2183787-2024-00021
- Event Type
- Injury
- Date Received
- March 21, 2024
- Report Date
- September 6, 2024
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- PMA / PMN Number
- P130012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
D4: UDIS WERE NOT USED WHEN SKU 200988-XXX WAS MANUFACTURED. THE GTIN IN THE GUDID DATABASE WILL NOT ALIGN WITH THE BARCODE AS NEW GTINS WERE ASSIGNED WHEN GBM TRANSITIONED TO THE GUDID SYSTEM. CLASS III DEVICES WERE REQUIRED TO REGISTER GTINS IN THE GUDID DATABASE ON 01-JUN-2013; THEREFOR, THE UDI FIELD (D4) IN FORM 3500A SHALL BE LEFT BANK AND WILL NOT ALIGN WITH THE GUDID ENTRY DUE TO THE DATE IT WAS MANUFACTURED.
Description of Event or Problem · 0
DEVICE WAS INFECTED AND EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2375890 | MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD | BIPOLAR EPICARDIAL LEAD | DTB | GREATBATCH MEDICAL | 511212 | W47550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |