FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2203811
·
Received August 11, 2011
Report
- Report Number
- 3004593495-2011-00076
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Manufacturer
- PLEXUS MANUFACTURING SDN. BHD.
- Product Code
- DSI
- PMA / PMN Number
- P890003/S154
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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 CARELINK MONITOR NOT RECEIVING POWER. VERIFIED POWER CORD IS CONNECTED AND TRIED DIFFERENT POWER OUTLETS. PATIENT HAS USED THE MONITOR BEFORE, MOST RECENTLY TRANSMITTED 16 DAYS PRIOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LATER REPORTED THE POWER CORD "WAS NOT COMING ON AND THEY WERE SENT A NEW POWER CORD THAT DID NOT HELP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PATIENT MONITORING INSTRUMENT | DSI | PLEXUS MANUFACTURING SDN. BHD. | 2490C8 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |