FDA Adverse Event
Injury
Summary report: N
ATLAS II VR
MDR report key: 4130736
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16187
- Event Type
- Injury
- Date Received
- September 30, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY IN (B)(6) 2013 FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENT DEVELOPED RHABDOMYOLYSIS AND RENAL FAILURE AND REMAINED IN THE HOSPITAL FOR SEVEN MONTHS. THE DEVICE WAS REPROGRAMMED AND THE PATIENTS MEDICATIONS WERE ADJUSTED. NO FURTHER INAPPROPRIATE THERAPIES OCCURRED THEREAFTER. THE PATIENT CONDITION HAS BEEN STABLE SINCE HOSPITAL DISCHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608376 | ATLAS II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-168 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |