FDA Adverse Event
Injury
Summary report: N
TRANSVENOUS PACEMAKER
MDR report key: 13257758
·
Received January 13, 2022
Report
- Report Number
- MW5106648
- Event Type
- Injury
- Date Received
- January 13, 2022
- Date of Event
- January 8, 2022
- Report Date
- January 11, 2022
- Manufacturer
- UNK
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
[BAMLANIVIMAB-ETESEVIMAB] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): THE PATIENT HAD A 35-SECOND EPISODE OF POLYMORPHIC VT/TORSADES. ARRHYTHMIA BEGAN WITH MULTIFOCAL PVCS. HE WAS SLEEPING WITH THE EPISODE AND HAD NO SYMPTOMS. ECG THIS AFTERNOON SHOWED QTC 553 MS WITH UNDERLYING IVCD. WE WILL INCREASE PACING RATE TO 90 BPM AND GIVE MAGNESIUM. STOP SSRI AND ANY OTHER QT PROLONGING DRUGS. PHARMACY REPORTS THAT THE COVID-19 TREATMENT HE RECEIVED IS ASSOCIATED WITH REPORTS OF BRADYCARDIA AND VARIOUS OTHER ARRHYTHMIAS. INFORMATIONAL AVAILABLE DOES NOT COMMENT ON WHETHER OR NOT QTC PROLONGATION IS A POTENTIAL SIDE EFFECT. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807153 | TRANSVENOUS PACEMAKER | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Life Threatening| H | AMIODARONE| ASPIRIN | BUPROPION| CITALOPRAM| HEPARIN | HYDROCORTISONE| INSULIN GLARGINE| ISOPROTERENOL | LEVOTHYROXINE| LORAZEPAM | MAGNESIUM| MUCINEX| PANTOPRAZOLE| POTASSIUM CHLORIDE |