FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1170680
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05814
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 19, 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 "SOME PROBLEMS WITH DRUG DELIVERY AND AN UNKNOWN PROBLEM WITH THE CATHETER". NO PATIENT SYMPTOMS WERE REPORTED. A DYE STUDY WAS PERFORMED ON THE PATIENT, AND IT WAS DISCOVERED THAT HE NEEDED A NEW CATHETER. THE PATIENT WAS PRESCRIBED ORAL MEDICATIONS WHILE WAITING FOR THE REVISION. NO VOLUME DISCREPANCIES WERE REPORTED. THE HCP PLANNED TO REPLACE THE CATHETER.
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 | 55 YR | Required Intervention | EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709| IMPLANTED: |