FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 2131696
·
Received June 16, 2011
Report
- Report Number
- 2183613-2011-00319
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 19, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S70
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
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 CONFIRMED THE CUSTOMER COMMENT: INTERCONNECT FLEX AND MAIN PRINTED CIRCUIT (PC) BOARD WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FUNCTIONAL TESTING BY THE BIOMEDICAL ENGINEER, THE OUTPUT WAS ERRATIC AND OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5348 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |