FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2120846
·
Received June 11, 2011
Report
- Report Number
- 3004593495-2011-00022
- Event Type
- Malfunction
- Date Received
- June 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
- VA, 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. EVALUATION SUMMARY: (B)(4): THE MONITOR WAS ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT THE CARELINK MONITOR IS NOT ABLE TO COMPLETE THE SEND PHASE OF THE REMOTE TRANSMISSION. PAST TRANSMISSIONS WERE SUCCESSFUL. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
(B)(4).
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 | 51 YR | Other | D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6945 IMPLANTABLE TACHY LEAD| 4196 IMPLANTABLE PACING LEAD| 5068 IMPLANTABLE PACING LEAD| 5068 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6945 IMPLANTABLE TACHY LEAD |