FDA Adverse Event
Injury
Summary report: N
PULSAR MAX
MDR report key: 1945556
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-19942
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 11, 2010
- Report Date
- October 11, 2010
- Manufacturer
- GUIDANT CLONMEL IRELAND
- Product Code
- NVZ
- Removal / Correction Number
- Z-875/897-03
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF THIS DATE, THE PACEMAKER HAS NOT BEEN RETURNED. IF THIS PACEMAKER SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRV RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED NOR COULD A MAGNET RATE BE OBTAINED. AS A RESULT, THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSAR MAX | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CLONMEL IRELAND | 1270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Life Threatening| R | 1270| (B)(4)| (B)(4) |