FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2954426
·
Received February 11, 2013
Report
- Report Number
- 2182208-2013-00442
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- December 22, 2012
- Report Date
- December 22, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE ELECTROCARDIOGRAM (ECG) CONNECTION WAS BROKEN. IT WAS ALSO NOTED THAT THE MICROPHONE WAS OUT OF ELECTRICAL SPECIFICATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER HAS A BROKEN ECG (ELECTROCARDIOGRAM) CONNECTION. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58056 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD |