FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2203391
·
Received August 11, 2011
Report
- Report Number
- 2183613-2011-00390
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- NVZ
- PMA / PMN Number
- P890003/S102
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THAT THE PATIENT CALLED TO STATE THAT WHEN THE PHONE IS PLUGGED INTO THE CARELINK MONITOR, THERE IS NO DIAL TONE. IF THE PHONE IS PLUGGED INTO THE WALL JACK, THERE IS A DIAL TONE. 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 | MEDTRONIC MILACA INC. | 2490C | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other | 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) TISSUE VALVE| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD |