FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2203357
·
Received August 11, 2011
Report
- Report Number
- 3004593495-2011-00050
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 11, 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
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S GIRLFRIEND THAT THE MONITOR LIGHTS CONTINUE TO BLINK AND THEY WEREN'T ABLE TO SEND A CARELINK TRANSMISSION. NO ADDITIONAL INFORMATION WAS PROVIDED FROM FOLLOW-UP. NO PATIENT COMPLICATIONS WERE 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 | 82 YR | Other | D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |