FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 3152690
·
Received June 7, 2013
Report
- Report Number
- 2182208-2013-01533
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 8, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
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 DISPLAY LENS WAS BROKEN. IT WAS ALSO NOTED THAT THE UPPER CASE WAS DENTED CAUSING IMPROPER LIE OF THE KEYBOARD, AND THE BATTERY CONTACTS WERE COMPRESSED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCREEN ON THE EPG (EXTERNAL PULSE GENERATOR) WAS CRACKED. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253230 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | RICE CREEK MFG | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |