FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 4112962
·
Received September 24, 2014
Report
- Report Number
- 3004209178-2014-17611
- Event Type
- Malfunction
- Date Received
- September 24, 2014
- Report Date
- September 23, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- 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 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE PUMP REVEALED AN ALARM ANOMALY/RESONATOR ANOMALY. A CRACK WAS FOUND ON THE RESONATOR. INTERROGATION OF THE PUMP SHOWED THAT IT HAD BEEN DELIVERING HYDROMORPHONE AND BUPIVACAINE.
Description of Event or Problem · 1
THE PUMP WAS RETURNED WITH NO INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596103 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |