FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2810443
·
Received October 31, 2012
Report
- Report Number
- 2183613-2012-01822
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 1, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S70
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 COULD NOT CONFIRM THE REPORTED EVENT. INTERMITTENT FAILURE OF THE FUNCTIONAL TEST; PROGRAMMER RECALIBRATED. LOWER CASE IS BROKEN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE BIOMEDICAL ENGINEER FOUND THAT THE RATE CONTROL WAS INACCURATE, UNRESPONSIVE OR SLOW TO RESPOND, AND DID NOT TRACK. THE EPG (EXTERNAL PULSE GENERATOR) 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. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |