FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1850913
·
Received September 29, 2010
Report
- Report Number
- 3004209178-2010-07433
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS DIMINISHING FOLLOWING SOME KIND OF ENVIRONMENTAL EXPOSURE, POSSIBLY A COLONOSCOPY OR ELECTROCAUTERY. THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS AND "COULD NOT MOVE." THE PATIENT WAS ADMITTED TO THE HOSPITAL. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization | LEAD: MODEL 3389, LOT# V004936| EXPLANTED:| PROGRAMMER: MODEL 7436, LOT# NFU017829P| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU131544V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU131545V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# V004936| EXPLANTED: |