FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1061439
·
Received June 17, 2008
Report
- Report Number
- 2182207-2008-03285
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 19, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A SEIZURE AND WOKE TO FIND PEOPLE TELLING HER THAT SHE HAD NOT BEEN "MAKING SENSE" WHEN SHE WAS TALKING AND THAT SHE WAS HEAVY/STRONG. THE PT'S MOUTH WAS BLEEDING FROM CHEWING IN HER MOUTH (SHE BIT HER DAUGHTER WHO WAS WIPING AWAY THE BLOOD). THE PT HAD TROUBLE REMEMBERING AND WAS CONFUSED. UPON WAKING, THE PT'S LEFT HAND WAS NUMB, WHICH LASTED FOR ONE AND ONE HALF WEEKS. IT WAS INDICATED THAT THE PT'S PUMP WAS LOW ON MEDICATION AND DUE TO BE REFILLED. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK| EXPLANTED:| CATHETER: MODEL 8711, LOT # J11171R44 |