FDA Adverse Event
Malfunction
Summary report: N
SYNCROMED
MDR report key: 3193087
·
Received June 27, 2013
Report
- Report Number
- 3007566237-2013-02131
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Report Date
- June 3, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THEY HAD REFILL ISSUES I.E. DIFFICULTY EITHER ASPIRATING/REFILLING THE REFILL PORT (SPECIFICATIONS NOT PROVIDED). REPORTER PROVIDED NO FURTHER INFORMATION IN REGARDS TO THE DEVICE/DRUG/PATIENT SYMPTOMS AND OUTCOME AT THE TIME OF THIS REPORT. A DDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS FURTHER NOTED THAT THE HEALTH CARE PROVIDER HAD NO FURTHER CLARIFYING DETAILS PERTAINING TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293407 | SYNCROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNWON |