FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2810794
·
Received October 31, 2012
Report
- Report Number
- 3007566237-2012-02598
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- October 5, 2012
- 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND NO ANOMALY. THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING. NO ANOMALIES NOTED IN PUMP LOGS.
Description of Event or Problem · 1
IT WAS REPORTED THAT PUMP AND CATHETER WERE REPLACED DUE TO BATTERY DEPLETION AND CATHETER TEAR. THE BATTERY DEPLETION WAS NORMAL. THE DISTAL CATHETER SEGMENT WAS FOUND TO BE FRACTURED AT V-WING. THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT. THE PATIENT WAS DOING WELL. THERE WAS NO PATIENT INJURY AND PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE WAS USED TO DELIVER GABLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |