FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 4102871
·
Received September 19, 2014
Report
- Report Number
- 3007566237-2014-02642
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- August 27, 2014
- Report Date
- August 27, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE WAS AT A PUMP REPLACEMENT CASE AND WAS ATTEMPTING TO UPDATE THE PUMP AND GOT A PUMP MEMORY ERROR. IT WAS NOTED THERE WERE SOURCES OF POTENTIAL EMI PRESENT. THE PUMP WAS RE-INTERROGATED AND REPROGRAMMING WAS CORRECT AND THE ISSUE WAS RESOLVED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PUMP WAS USED TO DELIVER CLONIDINE, BUPIVACAINE AND DILAUDID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585242 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00047 YR |