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

Model Number 8637-20

Device Problem Occlusion Within Device (1423)

Patient Problems Diarrhea (1811); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Therapeutic Response, Decreased (2271); Malaise (2359); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Lethargy (2560)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8780, serial (b)(4), implanted: (b)(6) 2015, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via a clinical study regarding a patient receiving hydromorphone 30 mg/ml for a total dose of 4.124 mg/day and bupivacaine 20 mg/ml for a total dose of 2.749 mg/day via an implantable pump for non-malignant pain.It was reported the patient reported increased low back and extremity pain on (b)(6) 2017.The patient complained of nausea, diarrhea, inadequate pain relief, and not feeling well on (b)(6) 2017.The patient reported shivering and stated they feel they are in withdrawal on (b)(6) 2017.Examination on (b)(6) 2017 found the catheter to be occluded.The patient reported lethargy and confusion on (b)(6) 2017.The patient reported all symptoms resolved and the patient stated they were pain free on (b)(6) 2017.The patient reported increased pain on (b)(6) 2017.The patient reported withdrawal symptoms, spasms, jerking, cannot hold items, and increased pain on (b)(6) 2017.The patient reported uncontrolled pain on (b)(6) 2018.Interventions included the pump was reprogrammed where they increased the basal rate on (b)(6) 2017, and on (b)(6) 2018.On (b)(6) 2017 medical or non-surgical therapy occurred where they flushed the occluded catheter.On (b)(6) 2017 the pump was reprogrammed where they decreased the pump by 50%.On (b)(6) 2018 other surgical intervention occurred where they revised the intrathecal catheter.On (b)(6) 2018 the pump was reprogrammed where they increased the basal rate and activated the personal therapy manager (ptm).The event resulted in in-patient or prolonged hospitalization.The device diagnosis was catheter occlusion.The clinical diagnosis was increased low back pain and bilateral lower extremity pain.The outcome of the event was noted as ongoing.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was noted as (b)(6) 2017.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare provider (hcp) via a clinical study indicated the cause of the catheter occlusion was not determined.The patient's baseline weight was (b)(6) pounds.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported the issue resolved without sequelae on (b)(6) 2018.It was noted the pain was controlled much better.

• 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: 7292471
• MDR Text Key: 100800298
• Report Number: 3004209178-2018-03850
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

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: 09/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 02/27/2018; 12/01/2018
• Supplement Dates FDA Received: 02/27/2018; 12/04/2018
• Date Device Manufactured: 04/11/2016
• 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: 74 YR
• Patient Weight: 109