FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1983041
·
Received February 4, 2011
Report
- Report Number
- 3007566237-2011-00906
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- January 1, 2007
- Report Date
- January 28, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) (UNABLE TO SPEAK). (B)(4).
Description of Event or Problem · 1
THE PT HAD A POCKET FILL 4 YEARS AGO AND WAS ADMITTED TO THE HOSP FOR 3 DAYS. THE PT WAS UNABLE TO SPEAK. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT 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 | 49 YR | Hospitalization | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8598, LOT# N002759717| CATHETER: MODEL 8709, LOT# J12173R19| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED:| EXPLANTED: |