FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2791495
·
Received October 15, 2012
Report
- Report Number
- 2183613-2012-01724
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- July 16, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) LCD (LIQUID CRYSTAL DISPLAY) IS MISSING SEGMENTS. UPPER AND LOWER CASES, SIDE BAIL COVERS, AND BATTERY DRAWER ARE BROKEN. THE RING IS BENT. KEYBOARD IS SCRATCHED.
Description of Event or Problem · 1
THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR CALIBRATION, ANALYZED AND TESTED OUT OF SPECIFICATION. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |