FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2790211
·
Received October 15, 2012
Report
- Report Number
- 2183613-2012-01606
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- August 13, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S70
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: FURTHER ANALYSIS FOUND NO ANOMALIES. THE DEVICE SIGNAL OUTPUT IS GOOD.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS TESTED AND THERE WAS NO OUTPUT. SERVICE REPORT HAS BEEN REQUESTED.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Description of Event or Problem · 1
FURTHER INFORMATION RECEIVED FROM THE CUSTOMER INDICATES THERE WAS NO SIGNAL OUTPUT FROM THE DEVICE.
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 |