FDA Adverse Event
Malfunction
Summary report: N
EMBLEM MRI S-ICD
MDR report key: 12218405
·
Received July 23, 2021
Report
- Report Number
- 2124215-2021-21046
- Event Type
- Malfunction
- Date Received
- July 23, 2021
- Date of Event
- September 11, 2019
- Report Date
- July 23, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526584404
- PMA / PMN Number
- P110042/S058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS PATIENT HAD RECEIVED INAPPROPRIATE SHOCKS ON TWO SEPARATE OCCASIONS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER THE MOST RECENT INAPPROPRIATE SHOCK. A BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS CONTACTED. REVIEW OF THE DEVICE DATA IDENTIFIED OVERSENSING OF T-WAVE MEASUREMENTS AND VARYING SIGNAL AMPLITUDES. THE REPRESENTATIVE SUGGESTED FURTHER TESTING, X-RAY AND PROGRAMMING OPTIONS FOR THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1113693 | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | A219 | 235283 | 00802526584404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |