FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 1874866
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-18051
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 8, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Removal / Correction Number
- Z-0187-06 THRU Z-0190-06
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE PRODUCT IS RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER WAS EXPERIENCING SYMPTOMS OF PACEMAKER SYNDROME. DURING THE DEVICE UPGRADE PROCEDURE, THE PACEMAKER WAS PROGRAMMED TO VOO MODE WITH A RATE OF 80PPM. UPON CAUTERIZING THE PACEMAKER POCKET TO GAIN ACCESS TO THE DEVICE, 2-3 BEATS OF PACING INHIBITION WERE NOTED ON THE EXTERNAL ELECTROCARDIOGRAM. THE PATIENT WAS PACEMAKER DEPENDENT AND BECAME SYMPTOMATIC. A DROP IN BLOOD PRESSURE WAS ALSO NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization| L | 439-07| 1194| 292-03| 430-10 |