FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3112296
·
Received May 14, 2013
Report
- Report Number
- 3004209178-2013-07644
- Event Type
- Injury
- Date Received
- May 14, 2013
- Report Date
- May 29, 2013
- 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
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, LOT # N183118011, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING REFILLS THERE WERE VOLUME DISCREPANCIES AND THERE WAS A YELLOWISH COLOR TO THE MEDICATION THAT WAS ASPIRATED. THE MEDICATION WAS CULTURED AND NO INFECTION WAS PRESENT. THE PATIENT HAD NO ADVERSE EVENTS. THE PUMP WAS REPLACED. THE PATIENT STATUS WAS REPORTED AS "ALIVE - NO INJURY/NO ADVERSE EVENT." THE PUMP WAS DELIVERING INFUMORPH AND BUPIVACAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212006 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Required Intervention |