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

Model Number 8637-20

Device Problems Filling Problem (1233); Migration or Expulsion of Device (1395); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Communication or Transmission Problem (2896); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer via a company representative regarding a patient receiving morphine 5mg/ml, dose not reported via an implantable pump.The indications for use was spinal pain.On (b)(6) 2018 it was reported the pump flipped.The healthcare provider was unable to complete the refill.The patient also stated difficulty getting the ptm (personal therapy manager) to communicate with the flipped pump but was eventually able to get it to work.It was noted that the earliest surgical intervention would be several days past low reservoir alarm date.The patient was brought back today, and the pump was manually manipulated and was then successfully filled.Morphine 6.1ml was expected to be withdrawn from the pump, however 16ml was removed indicating a possible catheter occlusion.The pump logs were read, and no motor stalls were indicated.A catheter dye studywas planned with possible replacement.The environmental, external or patient factors that may have led or contributed to the issue was noted as the patient has had no falls or traumatic injury and has maintained current weight since implant.The actions and interventions taken to resolve the issue surgery was planned but not yet scheduled.The issue was not resolved at the time of the event and it was noted that the healthcare provider would not have any further information regarding the event.The patient¿s status was noted as alive, no injury and no further complications were reported.

Manufacturer Narrative

Product id 8780 lot# (b)(4)implanted:(b)(6)2017 explanted: product type catheter product id 8780 lot# (b)(4) implanted: (b)(6)2017 explanted: product type catheter.Other relevant device(s) are: product id: 8780c , (b)(4), (b)(4) other relevant device(s) are: product id: 8780 ,(b)(4)(b)(4) ,(b)(4) if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 27-jun-2018 from a healthcare professional via a company representative who reported that a pump dye rotor study was attempted on (b)(6)2018, but under x-ray the catheter was visualized wrapped around the pump and the physician did not want to tryto access the catheter access port with the possibility that the access needle would damage the catheter.The pump dye rotor study was then cancelled.The patient was going to be scheduled for revision surgery.No further complications were reported/anticipated.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated: patient code (b)(4) no longer applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer who reported that the neurosurgeon told the patient the pump was only working at 20% due to the issues with flipping.The neurosurgeon had to ¿un-flip¿ the pump in (b)(6).The patient stated she has lost total control of her pain and cannot get it back.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received on 08-nov-2018 from a healthcare professional who reported that during the procedure in (b)(6), the pump pocket was revised; the pump was sutured; and the catheter was untangled.The pump was not explanted.After the revision, the patient¿s pump dose was reduced for safety and was the cause for the patient¿s pain after the revision.The dose was titrated to resolve the patient¿s pain.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter; product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a patient.The patient reported the pump was only working at 20% because the catheter was so kinked.No further complications were anticipated/reported.

• 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
• MDR Report Key: 7595973
• MDR Text Key: 110879361
• Report Number: 3004209178-2018-13284
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 86