FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3130116
·
Received May 24, 2013
Report
- Report Number
- 3004209178-2013-08185
- Event Type
- Injury
- Date Received
- May 24, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-2276-2009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A LOW BATTERY WAS REPORTED. THE PATIENT¿S PUMP WAS REPLACED ON (B)(6) 2013. THE PATIENT¿S SYMPTOMS INCLUDED INCREASING PAIN. THE PUMP¿S ELECTIVE REPLACEMENT INDICATOR WAS LESS THAN SEVEN MONTHS. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.
Description of Event or Problem · 1
CORRECTION - THE MEDICATIONS USED WITHIN THE SYSTEM WERE SUFENTA AND BUPIVACAINE.
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT, AS OF (B)(6) 2013, THE PUMP EARLY REPLACEMENT INDICATOR WAS LESS THAN SEVEN MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230813 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Required Intervention |