FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 3191332
·
Received June 26, 2013
Report
- Report Number
- 3007566237-2013-02121
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Report Date
- June 4, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WITHIN THE LAST TWO MONTHS, A VERY OLD PUMP WAS REPLACED; IT HAD A TIE ON CONNECTOR BETWEEN THE PUMP NIPPLE AND THE CATHETER. THE TIE HAD ERODED THE PLASTIC. IT RESULTED IN CSF (CEREBROSPINAL FLUID) IN THE POCKET AND/OR THE CATHETER WAS OBSTRUCTED BY THE INVADING SCAR TISSUE; IT WAS UNCLEAR WHICH HAPPENED IN THIS CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT FOR THIS PATIENT THE NIPPLE WAS "VISIBLY WORN WITHOUT MALFUNCTION". THE CATHETER WAS LESS THAN 7 YEARS OLD. THE EVENT HAPPENED WITHIN THE LAST YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290875 | SYNCHROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |