FDA Adverse Event
Injury
Summary report: N
VITALITY 2
MDR report key: 1871690
·
Received October 15, 2010
Report
- Report Number
- 2124215-2010-18740
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- August 29, 2010
- Report Date
- June 12, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Removal / Correction Number
- Z-1293-06 THRU Z1299-06
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS ELECTIVELY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS CONFIRMED TO BE UNAVAILABLE FOR RETURN FOR ANALYSIS.
Additional Manufacturer Narrative · 1
EVENT CLARIFICATION AND RESOLUTION WERE REQUESTED FROM THE FIELD REPRESENTATIVE. THE REPRESENTATIVE WAS NOT AWARE OF THE ISSUE AND STATED THAT PERHAPS THE HOSPITAL STAFF PERFORMED THE DEVICE CHECK. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED SYNCOPE. THE CAUSE WAS NOT DEFINED. NO FURTHER PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | T175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | 6949| T175 |