MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial# (b)(4), product type: programmer, patient.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.(b)(4).

Event Description

Information was received from a consumer regarding a patient receiving intrathecal fentanyl (concentration 1000mcg/ml; dose 287mcg/day) via an implantable infusion pump.Patient history included non-malignant pain.The dates on the patient's personal therapy manager (ptm) were incorrect and the lockout interval allowed for boluses even though only 2 minutes had passed.The patient stated that sometime he could give more than what he was allowed and sometimes less than what he was allowed.The event occurred in (b)(6) 2015.No patient symptoms were reported.The event was not resolved as of the date of the report.Additional information has been requested but was not available at the time of this report.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5033227
• MDR Text Key: 24955654
• Report Number: 3004209178-2015-16788
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00053 YR