FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 1922117
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05859
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 8, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT SHE SEES STARS, FEELS LIKE SHE IS GOING TO PASS OUT WHEN AT WORK. IT WAS ALSO REPORTED BY THE PATIENT THAT HER WHOLE BODY FELL OVER AND COULDN'T SEE FOR A MINUTE 3 TIMES IN 20 MINUTES ONE DAY. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other | 4024 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |