FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2963946
·
Received February 15, 2013
Report
- Report Number
- 3007566237-2013-00504
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Report Date
- January 18, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: UNKNOWN. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PUMP HAD BEEN TURNED OFF AND HAD REACHED END OF LIFE (EOL). THAT WAS THE REASON IT WAS NOT WORKING. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS BECAUSE SHE WAS BEING MANAGED BY ORAL MEDICATION. THE PUMP HAD NOT BEEN EXPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS PUMP DID NOT "WORK". THE PUMP WAS FILLED WITH SALINE. THE DRUG IN THE PUMP WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67554 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |