FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1960937
·
Received January 11, 2011
Report
- Report Number
- 3007566237-2011-00264
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 5, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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 WAS HAVING SURGERY TO SEE IF THERE WERE ANY ISSUES WITH THE CATHETER. THEY WERE ALSO DECIDING IF THEY SHOULD REPLACE THE PUMP AT THE SAME TIME. THE REPORTER WAS NOT AWARE OF ANY THERAPY ISSUES WITH THE PT. 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 | 13 YR | Other | CATHETER: MODEL 8709, LOT #: J12277R02| IMPLANTED:| EXPLANTED: |