FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 4924725
·
Received July 20, 2015
Report
- Report Number
- 3004209178-2015-13630
- Event Type
- Malfunction
- Date Received
- July 20, 2015
- Date of Event
- June 29, 2015
- Report Date
- June 29, 2015
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N140414, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
DURING THE ROUTINE PUMP REPLACEMENT PROCEDURE, THE PHYSICIAN ACCIDENTLY CUT THE CATHETER WHICH NECESSITATED REVISION OF THE CATHETER. THE PATIENT HAD NO SYMPTOMS RELATED TO THE EVENT. THE DEVICE SYSTEM WAS DELIVERING LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470385 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR |