FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2201929
·
Received August 11, 2011
Report
- Report Number
- 2183613-2011-00347
- 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
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 THAT ALL OF THE INDICATOR LIGHTS ON THE CARELINK MONITOR WERE BLINKING. ATTEMPT TO "RESET" THE MONITOR WAS UNSUCCESSFUL. THE MONITOR WILL BE REPLACED. 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 | MEDTRONIC MILACA INC. | 2490C | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other | 6935 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEADS| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |