FDA Adverse Event
Injury
Summary report: N
ACCOLADE
MDR report key: 7349907
·
Received March 19, 2018
Report
- Report Number
- 2124215-2018-01842
- Event Type
- Injury
- Date Received
- March 19, 2018
- Date of Event
- December 29, 2017
- Report Date
- January 2, 2018
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- UDI-DI
- 00802526559174
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED AND DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. THE CONSULTANT SUGGESTED THE PATIENT PERFORM A PATIENT INITIATED INTERROGATION (PII) HOWEVER, PII'S HAD NOT BEEN ENABLED FOR THIS PATIENT. THE PATIENT WAS REFERRED TO HER FOLLOWING CLINIC.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192793 | ACCOLADE | IMPLANTABLE PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | L301 | 00802526559174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Life Threatening| O | 7740| 7741| L301 |