FDA Adverse Event
Injury
Summary report: N
INSYNC
MDR report key: 4162496
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02518
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 4, 2014
- Report Date
- August 4, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: COMPETITOR LEAD, IMPLANTED: (B)(6) 2000. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET (POR) WHEN THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN. THE DEVICE WAS REPROGRAMMED TO OPERATE IN THE ORIGINAL SETTINGS AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 644703 | INSYNC | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | IPG MFG SWITZERLAND | 8040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00091 YR | Required Intervention | 4193 LEAD |