FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 4842213
·
Received June 12, 2015
Report
- Report Number
- 3007566237-2015-01645
- Event Type
- Malfunction
- Date Received
- June 12, 2015
- Report Date
- May 20, 2015
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # J0056661R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER; PRODUCT ID 8575, LOT # J12305R, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HEARD THE PUMP ALARM ONCE BEFORE. THE PATIENT HAD MISSED THEIR REFILL AND THE LOW RESERVOIR ALARM HAD SOUNDED. IT OCCURRED IN 2009. IT WAS UNKNOWN WHAT THE PUMP SYSTEM WAS DELIVERING. NO SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385991 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR |