FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4111408
·
Received September 23, 2014
Report
- Report Number
- 3004209178-2014-17591
- Event Type
- Injury
- Date Received
- September 23, 2014
- Report Date
- August 28, 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703W, LOT# L41563, IMPLANTED: (B)(6) 1996, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A PUMP REPLACEMENT, THE HEALTH CARE PROVIDER REALIZED THAT SOMETHING WAS WRONG WITH THE CATHETER. A DYE STUDY WAS PERFORMED THE DAY PRIOR TO THE DATE OF THIS REPORT, BUT NO CEREBROSPINAL FLUID WAS ABLE TO BE ASPIRATED THROUGH THE CATHETER ACCESS PORT. ON THE DATE OF THIS REPORT, THE CATHETER WAS REPLACED, AND NO VISIBLE PROBLEMS WITH THE CATHETER WERE OBSERVED. THE PATIENT WAS DOING WELL AND DID NOT HAVE ANY SYMPTOMS. THE DRUG IN THE PUMP WAS GABLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590476 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |