FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2230564
·
Received August 12, 2011
Report
- Report Number
- 3004209178-2011-06296
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 21, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- 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 SOME REBOUND SPASTICITY. THE DISTAL SEGMENT OF THE CATHETER HAD MIGRATED/DISLODGED OUT OF THE INTRATHECAL SPACE. THE PT'S CATHETER WAS REVISED ON (B)(6) 2011. FOLLOWING THE REVISION AS OF (B)(6) 2011, THE PT WAS RECEIVING EFFECTIVE DRUG THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N275971001 |