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

Model Number 8637-20

Device Problems Failure to Interrogate (1332); Unstable (1667)

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

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id neu_ptm_prog, product type: programmer, patient.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with an implanted infusion pump containing unknown medications.The indications for use included non-malignant pain, failed back surgery syndrome, and post lumbar laminectomy syndrome.It was reported that on (b)(6) 2016, the representative was having difficulty establishing communication between the patient's new ptm and the pump.The ptm was decoupled, but the representative had difficulty recoupling the ptm as well.An antenna was tried, but the issue remained unresolved.The patient was using a powered wheelchair and diaper at the time, and the last refill was on (b)(6) 2016.Recommended troubleshooting included moving to another location, placing the antenna directly over the skin, turning off the power to the wheelchair or removing the wheelchair, and checking to see if the pump may be flipped.On (b)(6) 2016, the representative reported that the ptm displayed the question mark symbol and not the bolus delivered icon.It was discovered that the pump had flipped.The healthcare provider flipped the pump back, and the ptm was able to communicate with the pump without the antenna.The pump appeared to be functioning properly, and a pump pocket revision was scheduled for (b)(6) 2016.No patient symptoms were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6106236
• MDR Text Key: 60016614
• Report Number: 3004209178-2016-24141
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• 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: 10/28/2016
• Date Device Manufactured: 08/27/2015
• 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
• Patient Age: 79 YR