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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Unstable (1667)

Patient Problems Muscular Rigidity (1968); Nausea (1970); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 03/31/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780.Serial (b)(4), implanted: (b)(6) 2018, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot (b)(4), ubd: 12-dec-2019, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device.The drugs being delivered were 1,052 mcg/ml baclofen (unknown) at 350 mcg/day, 14 mg/ml dilaudid at 4.65 mg/day, and 105.4 mcg/ml clonidine at 35 mcg/day.The reason for use was not reported.It was reported that the patient started to experience withdrawal symptoms from baclofen on (b)(6) 2018.The patient had a return of spasticity and was feeling nauseous and ill from withdrawal symptoms.They were admitted to hospital and a revision was scheduled for the morning of (b)(6) 2018.The doctor could tell the pump was flipping in the pocket just by feeling his abdomen.He opened the pocket to find that the pump portion was kinked and wound up several times in the pocket.The pump segment catheter was completely twisted and it appeared the pump was likely flipping in the pocket which caused this.He replaced the twisted portion with a new pump segment piece 8784.He was then able to aspirate the catheter and empty it with good flow.He also placed a mesh pouch in the pocket to help stabilize it better along with non-absorbable sutures.The pump was programmed at the end and they primed the catheter portion only, and resumed the old daily dose.The customer was notified that the product should be returned to the manufacturer, but it will not be returned as the customer refuses.Environmental/external/patient factors that may have led or contributed to the issue included the patient is wheelchair bound and gets help with transfers.There were no diagnostics performed.The issue was resolved at the time of the report.The hcp would have no further information on this event.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the hcp on 2018-apr-26.It was reported that the cause of the flipped pump was that the ¿sutures ripped out a second time ¿ mesh pouch used.¿ the ¿sutures pulled out, pump rotated, kinking catheter.¿ the withdrawal symptoms had resolved.There were no further complications reported/anticipated.

• 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: 7399049
• MDR Text Key: 104450981
• Report Number: 3004209178-2018-06520
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 04/30/2018
• Date Device Manufactured: 11/08/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR