FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4090461
·
Received September 15, 2014
Report
- Report Number
- 3004209178-2014-17051
- Event Type
- Injury
- Date Received
- September 15, 2014
- Report Date
- August 21, 2014
- 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
- PHYSICIAN
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 THAT "THE STRUCTURES AND ADHESION THAT GROWN AROUND THE PUMP WERE LOOSE AND THE HEALTHCARE PROVIDER (HCP) HAD TO GO IN." IT WAS CLARIFIED BY THE PHYSICIAN THAT ONCE IN A WHILE THE PATIENT WAS HAVING A "TWINGE OF PAIN AT THE PUMP SITE, NON-CONSISTENT." IT WAS A DEVICE POSITIONING ISSUE, THERE WAS PUMP MOVEMENT IN THE POCKET, THE PUMP POCKET WAS ENLARGED" THE POCKET WAS SURGICALLY REVISED ON (B)(6) 2013. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP SYSTEM WAS DELIVERING HYDROMORPHONE AND BUPIVACAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570284 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |