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

Model Number 8637-20

Device Problems Kinked (1339); Unstable (1667); Aspiration Issue (2883)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Twiddlers Syndrome (2114)

Event Type  Injury  

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient receiving dilaudid (2 mg/ml at.5 mg/day) via an implantable infusion pump.It was reported that the patient complained of increase pain and a refill appointment.A dye study was attempted but the healthcare provider (hcp) was unable to aspirate the catheter.It was unknown if any environmental/external/patient factors that may have led or contributed to the issue.A catheter revision was performed.During the surgery the hcp opened the lumbar incision and cut the catheter to check for cerebrospinal fluid flow , the flow was noted as not good.When the hcp opened the pump pocket to check there he found that the catheter was completely kinked and wound several times in the pocket.It was reported that the hcp thinks that the patient was playing with the pump and flipping it.The pump segment of the catheter was replaced with a new piece from a 8781 kit and connected to the working spinal piece.The portion of the explanted catheter would not be returned due to the customer's refusal.It was reported that the pump was decreased from dilaudid.5 mg/day to.1 mg/day per the hcp.The issue was noted as resolved and the patient was alive with no injury.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative.The indications for use were noted to be failed back surgery syndrome, chronic low back pain, and spinal pain.It was reported that the patient was not getting pain relief.It was reported that the patient's status at the time of the report was alive with injury, which contradicts the information in the previous report that stated that the patient's status was alive- no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Updated section; (b)(6) 2018; (b)(4): information was received from a consumer via a device manufacturer representative regarding a patient receiving dilaudid (2 mg/ml at.5 mg/day) via an implantable infusion pump.It was reported that the patient complained of increased pain at a refill appointment.A dye study was attempted but the healthcare provider (hcp) was unable to aspirate the catheter.It was unknown if any environmental/external/patient factors that may have led or contributed to the issue.A catheter revision was performed.During the surgery, the hcp opened the lumbar incision and cut the catheter to check for cerebrospinal fluid flow, the flow was noted as not good.When the hcp opened the pump pocket, they found that the catheter was completely kinked and wound several times in the pocket.It was reported that the hcp thought that the patient was playing with the pump and flipping it.The pump segment of the catheter was replaced with a new piece from a 8781 kit and connected to the working spinal piece.The portion of the explanted catheter would not be returned due to the customer's refusal.It was reported that the pump was decreased from dilaudid 0.5 mg/day to 0.1 mg/day per the hcp.The issue was noted as resolved and the patient was alive with no injury.No further complications have been reported as a result of this event.New section; on 2018-may-29, additional information was received from the manufacturer representative (rep) which was confirmed with the physician/account.Additional information reported the refill date was (b)(6) 2018.

• 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: 7545163
• MDR Text Key: 109289341
• Report Number: 3004209178-2018-11903
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• 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: 05/29/2018
• Date Device Manufactured: 04/05/2017
• 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: 84 YR