FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 2143002
·
Received June 23, 2011
Report
- Report Number
- 3007566237-2011-04718
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 26, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S PUMP WAS REPLACED BECAUSE, THE PUMP HAD REACHED ITS END OF SERVICE. DURING THE PROCEDURE, A DEFECT ON THE CONNECTION ON THE SUTURELESS CONNECTOR WAS OBSERVED. THE CATHETER WAS ALSO COMPLETELY REPLACED AND CONNECTED TO THE NEW PUMP. THE PT WAS FINE FOLLOWING THE SURGERY. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EXPLANTED:| CATHETER: MODEL 8731SC, LOT# UNK| IMPLANTED: |