FDA Adverse Event
Malfunction
Summary report: N
MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD
MDR report key: 18210213
·
Received November 27, 2023
Report
- Report Number
- 2183787-2023-00072
- Event Type
- Malfunction
- Date Received
- November 27, 2023
- Date of Event
- July 4, 2023
- Report Date
- November 3, 2023
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- UDI-DI
- 00802526483714
- PMA / PMN Number
- P130012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
UDI RELATED DATA QUALITY UPDATES ONLY. H2: CORRECTION MARKED. DIFFERENT UDIS WERE USED WHEN SKU 200988-XXX WAS MANUFACTURED. WHEN GREATBATCH (GBM) TRANSITIONED TO GS1- 128 BARCODES, THE GTIN FOR SKU 200988-XXX WAS ASSIGNED. 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 WILL NOT ALIGN WITH THE GUDID ENTRY DUE TO THE DATE IT WAS MANUFACTURED."
Description of Event or Problem · 0
RIGHT VENTRICULAR PACING LEAD AND ATRIAL PACING LEAD IMPEDANCE MEASUREMENTS WERE GREATER THAN 3000. THE DEVICE WAS EXPLANTED IN JULY. THIS EVENT IS RELATED TO 2183787-2023-00073.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1240441 | MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD | BIPOLAR EPICARDIAL LEAD | DTB | GREATBATCH MEDICAL | 511212 | W4479184 | 00802526483714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |