FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE PULSE GENERATOR
MDR report key: 1873836
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17540
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 31, 2010
- Report Date
- September 21, 2010
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 DEVICE EXPERIENCED SYNCOPAL EPISODES. THE PATIENT TRIGGERED STORED ELECTROGRAMS SHOW A SLOW RHYTHM. THE PATIENT HAS SEEN A NEUROLOGIST AND THEY WANT TO DO PERFORM MAGNETIC RESONANCE IMAGING.
Description of Event or Problem · 1
INFORMATION WAS LATER RECEIVED THAT THE PATIENT MIGHT BE SYMPTOMATIC TO VENTRICULAR PACING.
Description of Event or Problem · 1
INFORMATION WAS LATER RECEIVED THAT THE DEVICE WAS CONFIRMED TO BE FUNCTIONING APPROPRIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT PUERTO RICO BV | BRADY DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |