FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2202916
·
Received August 11, 2011
Report
- Report Number
- 3004593495-2011-00048
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 5, 2011
- Manufacturer
- PLEXUS MANUFACTURING SDN. BHD.
- Product Code
- NVZ
- PMA / PMN Number
- P890003/S154
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT SAW THE POWER LIGHT ON THE CARELINK MONITOR (CLM) WAS AMBER COLORED ON TWO OCCASIONS RATHER THAN GREEN. THE CLM 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 |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PATIENT MONITORING INSTRUMENT | NVZ | PLEXUS MANUFACTURING SDN. BHD. | 2490C8 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |