FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 1863280
·
Received October 9, 2010
Report
- Report Number
- 2183613-2010-00237
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- ASKU
- 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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE DEVICE WOULD NOT POWER UP. THE CAUSE WAS THE MAIN PCB (PRINTED CIRCUIT BOARD). THE UPPER AND LOWER CASES AND RING COVER WERE ALSO FOUND TO BE BROKE, BATTERY RELEASE CONTAMINATED, AND BATTERY CONTACTS COMPRESSED.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WILL NOT STAY ON. FOLLOW-UP INFORMATION RECEIVED DETERMINED 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. | 5388 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |