FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 1863266
·
Received October 9, 2010
Report
- Report Number
- 2183613-2010-00209
- 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
- NC, 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 LCD LENS WAS FOUND TO BE BROKE AND LEAD FLEX COVER CORRODED. THE RING AND SIDE BAIL COVERS, RING, AND SIDE BAILS WERE MISSING. THE BATTERY RELEASE, BATTERY DRAWER, HEART BLOCK, AND HEART WIRE CONTACTS WERE CONTAMINATED.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE DOES NOT TURN ON. NO PATIENT INVOLVEMENT OR 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 |