FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3970917
·
Received July 31, 2014
Report
- Report Number
- 3004209178-2014-13758
- Event Type
- Injury
- Date Received
- July 31, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) INDICATING AN OVERDOSE OCCURRED. SYMPTOMS INCLUDED ACUTE ALTERED MENTAL STATUS AND OVERDOSE. THEY BELIEVED THE PATIENT HAD A RECENT DOSING CHANGE. THEY HAVE USED NARCAN AND PAGED THE ON-CALL PHYSICIAN FOR THE PUMP. THEY WERE WONDERING HOW TO STOP THE PUMP. OPTIONS OF EMPTYING THE PUMP RESERVOIR OR PROGRAMMING THE PUMP TO STOP PUMP MODE WERE DISCUSSED. THE HCP DID NOT HAVE A PROGRAMMER. A MEDTRONIC REPRESENTATIVE WAS PAGED TO COME OVER AND STOP AND PUMP. THE MEDICATION INFUSED WAS MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448269 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Required Intervention |