FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202384
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-03061
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- April 2, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N230604, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HEARD A CRITICAL ALARM IN THE AM ON (B)(6) 2012. THE PATIENT MISSED HIS REFILL DATE WHICH WAS ON (B)(6) 2012. THE PATIENT INQUIRED ABOUT HOW FREQUENTLY ALARMS SOUND. THE PATIENT REPORTED RETURN OF SYMPTOMS, HEADACHE AND INCREASED PAIN. THE PATIENT WAS SCHEDULED AN APPOINTMENT WITH THE HEALTH CARE PROVIDER AT 2 PM ON (B)(6) 2012. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302989 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR |