CARELINK
Report
- Report Number
- 3004593495-2011-00012
- Event Type
- Malfunction
- Date Received
- June 11, 2011
- Manufacturer
- PLEXUS MANUFACTURING SDN. BHD.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S154
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: A CORRECTION TO MODEL NUMBER WAS MADE TO REFLECT CORRECT MODEL AS 2490C8.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
PRODUCT EVALUATION SUMMARY: THE MONITOR WAS RETURNED AND ANALYSIS REVEALED THAT THE TESTER WAS UNABLE TO SIMULATE THE FAILURE. THE CONCLUSION OF ANALYSIS REVEALED THAT THE PCBA COMPONENT FAILURE COMPLAINT WAS CONFIRMED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
IT WAS REPORTED THAT SINCE A STORM WENT THROUGH THE CARELINK MONITOR IS NOT RECEIVING POWER. A NEW POWER CORD WILL BE SENT. THE DEVICE IS STILL IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
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 | DXY | PLEXUS MANUFACTURING SDN. BHD. | 2490C8 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4196 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |