FDA Adverse Event
Injury
Summary report: N
NONE
MDR report key: 1926138
·
Received December 14, 2010
Report
- Report Number
- 2182208-2010-01013
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- August 1, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KFJ
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 THE DEVICES WERE REMOVED DUE TO POCKET INFECTION AND EROSION. BLOOD CULTURES INDICATED (B)(6); PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | LEAD SERVICE KIT | KFJ | MEDTRONIC, INC. | 5867 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD| 1388T COMPETITOR IMPLANTABLE PACING LEAD| D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB |