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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Difficult to Interrogate (1331)

Patient Problems Pocket Erosion (2013); Scarring (2061); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 02/04/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015 the healthcare professional (hcp) was unable to get telemetry to the pump.Two different programmers were used without obtaining telemetry and the hcp did not do the refill.The manufacturer¿s representative was asked to be at the facility (b)(6) 2015 when they were going to attempt again.The reporter noted that the hcp often attempted telemetry when the patient was in a wheelchair.The reporter did not know whether the appropriate programmer or application was being used, whether there were sources of potential emi (electromagnetic interference) present, if the hand was positioned over the programming head, or if the telemetry head was being correctly positioned over the pump.There was no therapy or medical problem reported and the patient was doing well with the therapy.The pump was used to infuse baclofen (compounded).No intervention or outcome was reported for this event.Follow up was being conducted to obtain further information.Should additional information be received it will be added to this event.On (b)(6) 2015, information was received from a manufacturer¿s representative and healthcare professional (hcp) regarding the patient receiving 2000mg/ml compounded baclofen at 470mcg/day since (b)(6) 2012.The patient also took 10mg lioresal and glucophage.The patient had a history of spinal injury-hemiplegia due to car accident.The indication for use was noted as intractable injury and post spinal cord injury.The manufacturer¿s representative tried for 30 minutes to get telemetry with the 8840 (clinician programmer) and was eventually able to do so ¿after lifting up on the pump edge and somewhat squeezing the telemetry head and pump together.¿ multiple programs were utilized with no change.Effort was made to rule out and resolve electromagnetic interference (emi); it was mentioned that the patient was in an electric wheelchair.The hcp indicated that the initial placement in the patient¿s side/flank was intentional due to the wheelchair, and now the felt it was not the best placement and planned to move the pump to the front/outer abdomen ¿within two weeks¿ ((b)(6) 2015).The patient was hitting the pump on things.The patient also had extreme fibrous tissue over the pump.They planned to replace the pump at the same time ¿since the life was more than half used.¿ the issue was not resolved at the time of this report.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# unknown, product type: programmer, physician.Product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from a healthcare provider via a company representative in regards to a patient who was being treated with compounded baclofen intrathecal (2000 mcg/ml; 582 mcg/day; lot number unable to be obtained).The patient had a medical history of a spinal cord injury.The patient's indication for pump use was post spinal cord injury and intractable spasticity.The patient's battery [pump] was located in the posterior lateral flank region of the patient.Beginning on approximately (b)(6) 2015, the pump was catching when the patient did transfers.As a result, the pocket was bruised on occasion.The patient was referred to a physician to move the pocket site to the abdomen and the catheter would be extended to accommodate.Per the request of the patient, the pump would also likely be changed because it was more than halfway through its battery life.The issue had not resolved as of the date of this report, but the patient was alive without injury.The surgery was scheduled for (b)(6) 2015.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015 the company representative was with the hcp and patient during a pre-op appointment.The plan was to relocate the pocket and replace the pump.It was discovered that the patient had a blister over their pump site which was red and warm.The patient then shared that they had been through 3 courses of antibiotics without resolve.The patient's dose was decreased on (b)(6) 2015.The plan was to admit the patient to the emergency room (er) on (b)(6) 2015 to further treat the possible infection.It was noted that they were unsure if it was superficial or within the surrounding tissues of the pump pocket.It was believed that the patient was last on cipro which was taken twice per day for the last couple of weeks.Before that the patient was on another antibiotic for 3 weeks and before that they were on a third antibiotic for another 3 weeks.The date of the event was (b)(6) 2015.

Event Description

Information was received from a healthcare provider via a company representative who indicated that the patient was in the hospital and his pump had eroded in the pump pocket and was exposed.As a result, the pump was explanted on the evening of (b)(6) 2016.There was no obvious infection and the catheter was also explanted at that time.The pump had been weaned to minimum rate flow of baclofen (23 mcg/day).The patient was using oral baclofen at 60 mg/day.

Manufacturer Narrative

Product id: 8840, serial# unknown, product type: programmer.Physician product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015-, product type: catheter.

Event Description

Additional information received from a healthcare provider (hcp) indicated the patient's medical history included paraplegia.The patient first began experiencing the erosion around (b)(6) 2015.The patient also experienced discomfort.X-rays indicated the pump and catheter were intact.The cause of the erosion was positioning.

Event Description

Additional information was received from a health care provider (hcp).The patient's other medications included metformin and morphine.The patient's medical history included diabetes, paraplegia, and obesity.The patient first started experiencing erosion in (b)(6) 2015.The patient experienced discomfort related to the erosion.A skin biopsy showed infection prior to the system explant.

• 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): 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: 4964240
• MDR Text Key: 6336566
• Report Number: 3004209178-2015-14571
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Date Device Manufactured: 08/21/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 00049 YR