FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 2130862
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03415
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- April 29, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- Z-1440-2010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
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): NO ANOMALIES FOUND, HOWEVER GROMMET DAMAGE WAS NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS BLOOD WAS IN THE HEADER MINUTES AFTER IMPLANT WHICH CAUSED OVERSENSING AND PACING INHIBITION ON THE ATRIAL CHANNEL. THE DEVICE WAS EXPLANTED AND REPLACED BY A NEW DEVICE. NO 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 | 56 YR | Hospitalization| R | 5076 (X2) IMPLANTABLE PACING LEADS |