FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1053257
·
Received May 28, 2008
Report
- Report Number
- 3004209178-2008-02848
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 28, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION.
Description of Event or Problem · 1
THE PUMP AND PROXIMAL PORTION OF THE CATHETER WERE EXPLANTED DUE TO INFECTION (SPECIFIC INFECTION SYMPTOMS NOT REPORTED). CULTURES WERE PENDING. THE DISTAL CATHETER WAS TIED OFF AND REMAINED IN PLACE. THE PT OUTCOME WAS 'NO INJURY', RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO ADMINISTER BUPIVACAINE AND DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 31 YR | Required Intervention | EXPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK| IMPLANTED:| CATHETER: MODEL 8731SC, LOT # N108346014 |