SYNCHROMED II INFUSION PUMP 8637-40 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-09 for SYNCHROMED II INFUSION PUMP 8637-40 N/A manufactured by Medtronic.

Event Text Entries

[17136784] Patient had intermittent symptoms of baclofen withdrawal and was hospitalized earlier this month. Pt had a baclofen pump contrast study which did not show a leak or break in the catheter system or a problem with the pump.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2658186
• MDR Report Key: 2658186
• Date Received: 2012-06-09
• Date of Report: 2012-06-06
• Date of Event: 2012-04-10
• Report Date: 2012-06-06
• Date Reported to FDA: 2012-06-09
• Date Added to Maude: 2012-07-17
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SYNCHROMED II INFUSION PUMP
• Generic Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Product Code: LKK
• Date Received: 2012-06-09
• Returned To Mfg: 2012-04-13
• Model Number: 8637-40
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: *
• Device Availability: R
• Device Age: 9 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC
• Manufacturer Address: 800 53RD AVENUE, N.E. MINNEAPOLIS MN 55421 US 55421

Device Sequence Number: 2

• Brand Name: INDURA 1P INTRATHECAL CATHETER
• Generic Name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
• Product Code: LNY
• Date Received: 2012-06-09
• Returned To Mfg: 2012-04-13
• Model Number: 8637-40
• Catalog Number: N/A
• Lot Number: N129564008
• ID Number: *
• Device Availability: R
• Device Age: 9 MO
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDTRONIC
• Manufacturer Address: 800 53RD AVENUE, N.E. MINNEAPOLIS MN 55421 US 55421

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-06-09
2	0		2012-06-09