FDA Adverse Event
Malfunction
Summary report: N
RHYTHMIA HDX
MDR report key: 13006812
·
Received December 14, 2021
Report
- Report Number
- 2134265-2021-15726
- Event Type
- Malfunction
- Date Received
- December 14, 2021
- Date of Event
- November 15, 2021
- Report Date
- December 14, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OAD
- UDI-DI
- 08714729966326
- PMA / PMN Number
- P150005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A CARDIAC MAPPING AND ABLATION PROCEDURE, AN ERROR OF D07 EXCESSIVE TEMP WAS OBSERVED ON THE MAESTRO SYSTEM. THE METRIQ TUBING WAS SECURED AND NO LEAKS WERE OBSERVED. THE CATHETER AND CABLE WERE EXCHANGED, HOWEVER THE ERROR PERSISTED. THE RHYTHMIA HDX MAESTRO G2 CATHETER CONNECTION BOX WAS NOTED TO BE FRAYED. AND ALSO REPLACED, HOWEVER, THE ERROR WAS NOT RESOLVED. THE PROCEDURE WAS CANCELLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1897878 | RHYTHMIA HDX | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | OAD | BOSTON SCIENTIFIC CORPORATION | 87031 | 1D826709 | 08714729966326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |