FDA Adverse Event
Malfunction
Summary report: N
VENTAK PRIZM
MDR report key: 2163205
·
Received July 15, 2011
Report
- Report Number
- 2124215-2011-07199
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 21, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR DUE TO CHARGE TIMES. THE PATIENT STATED THAT THEY WERE TOLD THE DEVICE WOULD LAST (B)(6). THIS DEVICE WAS SCHEDULED TO BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK PRIZM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | 1852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | (B)(4)| (B)(4)| (B)(4) |