FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2140963
·
Received June 21, 2011
Report
- Report Number
- 3007566237-2011-04630
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 26, 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'S PUMP HAD NOT BEEN FILLED SINCE (B)(6) 2009. IN (B)(6) 2011, THE PUMP WAS ALARMING. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING; THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE PT WAS SUPPLEMENTED WITH ORAL BACLOFEN AND REFERRED TO A NEUROSURGEON FOR PUMP REPLACEMENT. THE PT HAD NO SYMPTOMS RELATED TO THE EVENT. THE PUMP WAS EXPLANTED. THE PT WAS MAINTAINING GOOD CONTROL WITH ORAL BACLOFEN. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN (500 MCG/ML).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N159311007 |