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

Model Number 8637-20

Device Problems Premature Discharge of Battery (1057); Pumping Stopped (1503); Device Displays Incorrect Message (2591); Battery Problem (2885); Inappropriate or Unexpected Reset (2959); Appropriate Term/Code Not Available (3191)

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

Event Date 05/27/2018

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A supplemental report will be submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving morphine (15 mg/ml at 0.091 mg/day) and clonidine (50 mcg/ml at an unknown dose) via an implantable infusion pump.The indication for use was noted to be non-malignant pain.It was reported that the patient's pump had premature battery depletion.Eleven motor stalls and recoveries were seen in the logs, beginning on (b)(6) 2018.The logs did not show earlier than that date.A "stopped pump period may exceed tube set" message was seen on (b)(6) 2018.A low battery reset was seen on (b)(6) 2018.Pump safe state occurred on (b)(6) 2018.Three more low battery resets were seen on the logs.The pump had reverted to minimum rate.It was noted there was surgery scheduled for the patient on (b)(6) 2018.No patient symptoms were reported.There were no known environmental, external or patient factors which may have led or contributed to the issue.The issue was not considered resolved.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable infusion pump (b)(4) found a feedthrough anomaly of shorting across the insulator.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7674270
• MDR Text Key: 113561725
• Report Number: 3004209178-2018-15418
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1579-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR