FDA Adverse Event
Injury
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2811126
·
Received October 31, 2012
Report
- Report Number
- 2183613-2012-01863
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 18, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S70
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. 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) NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) WAS CONNECTED TO THE PATIENT. WHEN STAFF OF A HOSPITAL LOOKED, THE EPG HAD STOPPED. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
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 | Required Intervention |