FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2315259
·
Received October 31, 2011
Report
- Report Number
- 3007566237-2011-08952
- Event Type
- Malfunction
- Date Received
- October 31, 2011
- Date of Event
- October 14, 2011
- Report Date
- October 14, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATHETER: MODEL: 8709SC, (B)(4), IMPLANTED ON: UNK, EXPLANTED ON: UNK; ACCESSORY: MODEL: 8590-1, LOT # N150385; PROGRAMMER: MODEL: 8840.
Description of Event or Problem · 1
IT WAS REPORTED THAT A BRIDGE BOLUS WAS INCORRECTLY PERFORMED "A FEW MOMENTS PRIOR". THE BOLUS WAS CANCELLED AND PUMP WAS UPDATED TO REFLECT DRUG/DOSE. THE DRUG/DOSE DELIVERED VIA THE DEVICE WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |