FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1230009
·
Received November 12, 2008
Report
- Report Number
- 3004209178-2008-07405
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- June 23, 2008
- Report Date
- October 13, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT SINCE IMPLANT WITH SYMPTOMS INCLUDING "UNDERTREATMENT OF PAIN". THE EMPTY RESERVOIR VOLUME ALARM WAS NOTED DUE TO A MISSED REFILL. NO CHANGE IN THE SYMPTOMS WAS NOTED WITH THE MISSED REFILL. THE VOLUME IN PUMP WAS BELOW RECOMMENDED VOLUME TO MAINTAIN ADEQUATE INFUSION. THE HCP "PULLED THE CATHETER INFERIORLY" AND PERFORMED A CATHETER DYE STUDY. THE CATHETER WAS NOTED TO BE IN SUBDURAL SPACE AND WAS KINKING. THE CATHETER WAS REPLACED. THE PUMP WAS FILLED WITH SALINE DURING THE SURGERY; REFILL WAS PLANNED FOR THE NEAR FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC| PROGRAMMER: MODEL 8840 |