FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1901961
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09464
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED PARALYSIS ON HER RIGHT SIDE AND IN HER FACE. A MANUFACTURER'S REP ADVISED HER TO SEEK MEDICAL CARE IMMEDIATELY. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other | IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N200982007| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N231082| IMPLANTED: |