FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2791106
·
Received October 15, 2012
Report
- Report Number
- 2183613-2012-01694
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- July 6, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 REPORTED EVENT. LCD (LIQUID CRYSTAL DISPLAY) IS MISSING SEGMENTS. SIDE BAIL COVERS ARE BROKEN AND SIDE BAILS ARE MISSING. HEART BLOCK IS CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT. KEYBOARD IS SCRATCHED (COSMETIC).
Description of Event or Problem · 1
IT WAS REPORTED THE LOWER DISPLAY OF THE EPG (EXTERNAL PULSE GENERATOR) WAS UNREADABLE, AND THE BELT CLIP WAS DAMAGED. IT WAS ALSO REPORTED THE BIOMED WAS DOING A CHECKOUT OF THE EPG AND FOUND THE LOWER DISPLAY HAS BLACK LINES IN IT. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |