FDA Adverse Event
Injury
Summary report: N
INSYNC III
MDR report key: 1990495
·
Received February 15, 2011
Report
- Report Number
- 6000094-2011-00224
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- September 16, 2010
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P010015/S005
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SPONTANEOUS DRAINAGE OF BROWN MATERIAL FROM THE LEFT EDGE OF THE DEVICE INCISION, ALONG WITH SWELLING AND TENDERNESS, AND DIAGNOSED WITH DEVICE IMPLANT SITE HEMATOMA. ANTIBIOTICS WERE GIVEN INTRAVENOUSLY TO THE PATIENT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC III | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | 8042 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R | 4194 IMPLANTABLE PACING LEAD| 4076 X2 IMPLANTABLE PACING LEAD |