FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2203806
·
Received August 11, 2011
Report
- Report Number
- 3004593495-2011-00075
- Event Type
- Malfunction
- Date Received
- August 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
- CT, 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.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAS TO FIRMLY PUSH THE POWER CORD INTO THE POWER OUTLET IN ORDER TO RECEIVE POWER. AS SOON AS THE PATIENT LETS GO, THE CARELINK MONITOR TURNS OFF. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | PLEXUS MANUFACTURING SDN. BHD. | 2490C8 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4568 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |