FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 3101275
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-02087
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- February 1, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
AT A ROUTINE FOLLOW-UP IT WAS DETERMINED THAT THE DEVICE HAD A DEVICE RESET. THE PATIENT REPORTS EXPERIENCING A SHOCK AND A CAR BATTERY SHOCK ON THE SAME DAY. THE DEVICE WAS REPROGRAMMED. THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204409 | ATLAS II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-268 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |