FDA Adverse Event
Injury
Summary report: N
CURRENT VR
MDR report key: 3892698
·
Received June 24, 2014
Report
- Report Number
- 2938836-2014-12286
- Event Type
- Injury
- Date Received
- June 24, 2014
- Date of Event
- May 21, 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
- TH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A MONOMORPHIC VT. THE RATE FELL BELOW THE PROGRAMMED PARAMETERS AND THE PATIENT DID NOT RECEIVE THERAPY. EXTERNAL DEFIBRILLATION WAS REQUIRED. THE DEVICE WENT INTO BACK-VVI MODE WITH NO HV THERAPY AVAILABLE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369355 | CURRENT VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | 1107-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | (B)(4) |