FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 2132014
·
Received June 16, 2011
Report
- Report Number
- 2183613-2011-00226
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE DEVICE WOULD NOT POWER UP. THE CAUSE WAS THE MAIN PCB (PRINTED CIRCUIT BOARD). THE BATTERY RELEASE WAS ALSO CONTAMINATED, THE UPPER AND LOWER CASES, TWO SIDE BAIL COVERS, AND RING COVER WERE BROKEN, AND THE RING WAS BENT.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR A MODIFICATION, DUE TO A MEDICAL DEVICE CORRECTION LETTER. IT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT OR COMPLICATIONS.
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 |