FDA Adverse Event
Malfunction
Summary report: N
BECKER EDMS II
MDR report key: 4919819
·
Received July 16, 2015
Report
- Report Number
- 2021898-2015-00258
- Event Type
- Malfunction
- Date Received
- July 16, 2015
- Date of Event
- June 15, 2015
- Report Date
- June 16, 2015
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- GWM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RETURNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL BECKER EDMS DEVICES ARE 100% LEAK TESTED AT THE TIME OF MANUFACTURE. ADDTIONAL PATIENT/DEVICE INFORMATION: ADDTIONAL INFORMATION REGARDING THE DEVICE LOT NUMBER AND EVENT DATE WAS RECEIVED BY MEDTRONIC NEUROSURGERY. (B)(4).
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RETURNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DRAIN BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464510 | BECKER EDMS II | DEVICE, MONITORING, INTRACRANIAL PRESSURE | GWM | MEDTRONIC NEUROSURGERY | 208764238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |