FDA Adverse Event
Injury
Summary report: N
PULSAR MAX II
MDR report key: 2162482
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07272
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- March 25, 2011
- Report Date
- April 19, 2011
- Manufacturer
- GUIDANT CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR TESTING AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EPISODE AND WAS IN THE EMERGENCY ROOM. DEVICE INTERROGATION WAS UNSUCCESSFUL AND SYSTEM EVALUATION NOTED PACING PAUSES. THE PATIENT STATED THE DEVICE WAS CHECKED A COUPLE OF MONTHS AGO AND WAS AT END OF LIFE (EOL). HOWEVER, THE PATIENT DOES NOT HAVE ANY HEALTH INSURANCE. THE DEVICE WAS EXPLANTED WITHOUT FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSAR MAX II | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CLONMEL IRELAND | 1280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |