FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2992373
·
Received March 7, 2013
Report
- Report Number
- 3007566237-2013-00710
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Report Date
- February 12, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-3043-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS REVEALED PUMP BATTERY HIGH RESISTANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HEARD A SINGLE TONE ALARM FROM THEIR DEVICE. THE PATIENT WAS HOSPITALIZED TO REPLACE THE PUMP FOR NORMAL BATTERY DEPLETION, END OF SERVICE. THERE WERE NO REPORTED PATIENT SYMPTOMS OR INJURIES. THIS DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96898 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |