FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2741370
·
Received September 12, 2012
Report
- Report Number
- 3007566237-2012-02208
- Event Type
- Injury
- Date Received
- September 12, 2012
- Report Date
- August 23, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- SEE H10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE RESERVOIR VOLUME WAS NOT SPECIFIED FOR THE MODEL # INDICATED, THEREFORE ALL POSSIBLE CORRECTION #'S WAS LISTED. Z-1150-2008 (20), Z-1151-2008 (40).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS DUE TO A LARGE MASS. IT WAS INDICATED THAT SURGICAL REVISION AND MASS REMOVAL WOULD TAKE PLACE THE FOLLOWING DAY. THE OUTCOME OF THE PATIENT AND THE DRUG IN THE PUMP WAS UNKNOWN. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
NO FURTHER INFORMATION RELATED TO THIS EVENT COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |