FDA Adverse Event
Malfunction
Summary report: N
BECKER EDMS II
MDR report key: 4192561
·
Received October 22, 2014
Report
- Report Number
- 2021898-2014-00414
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 24, 2014
- Report Date
- September 25, 2014
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K984053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED UNIT WAS PATENT AND IT MET REQUIREMENTS FOR THE LEAKAGE TEST. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT 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 CONNECTION BETWEEN THE BECKER EDMS AND A THIRD PARTY TRANSDUCER WAS LEAKING. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671722 | BECKER EDMS II | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | 208500489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR |