FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 2131384
·
Received June 16, 2011
Report
- Report Number
- 2183613-2011-00264
- Event Type
- Malfunction
- Date Received
- June 16, 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
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) BATTERY CONTACTS FOUND COMPRESSED. LCD DISPLAY OUT OF SPECIFICATION (SEGMENT MISSING), RING BENT, AND UPPER AND LOWER CASES BROKEN.
Description of Event or Problem · 1
THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
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 |