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

Model Number 8637-20

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 04-mar-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative regarding a patient who was receiving 10mg/ml dilaudid at "0.5mg," via an implantable infusion pump for an unknown indication for use.It was reported that the patient was not getting relief.The hcp performed a dye study and rotor study.The rotor study was negative, but the hcp was unable to aspirate the catheter during the dye study.The hcp still believed there was something wrong with the pump.There was a volume discrepancy where they expected to pull 12.7cc and actually pulled 16.5cc.The pump and catheter were replaced on (b)(6) 2018, and it was reported the issue was resolved.The patient's status at the time of the report was noted as "alive-no injury." no further complications were anticipated/reported.

Manufacturer Narrative

Analysis found no significant anomalies.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7532357
• MDR Text Key: 108850548
• Report Number: 3004209178-2018-11464
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• 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 Outcome(s): Required Intervention