FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 2123876
·
Received June 14, 2011
Report
- Report Number
- 2183613-2011-00138
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- March 3, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- Z-0430-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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. EVALUATION SUMMARY: (B)(4) ANALYSIS FOUND THE HEART LEAD FLEX WAS OUT OF SPECIFICATION, THE LCD WINDOW WAS BROKEN, AND ONE BAIL COVER WAS BENT. THE MAIN PRINTED CIRCUIT BOARD WAS ALSO REPLACED DUE TO THE FIELD ADVISORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EPG (EXTERNAL PULSE GENERATOR) SHUT DOWN DURING USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |