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

Model Number 8637-20

Device Problem Occlusion Within Device (1423)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

The other relevant components include: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving morphine 40mg/ml for a total dose of 7.358mg/day and unknown baclofen 250mcg/ml for a total dose of 45.99mcg/day via an implantable pump for non-malignant pain and chronic low back pain.It was reported on (b)(6) 2017 the patient reported being woken in their sleep 10 days prior to sudden spastic contracture in their legs, which has persisted.Also on (b)(6) 2017 the patient also experienced increased pain and was experiencing some withdrawal symptoms.Surgical observation on (b)(6) 2017 found a sluggish catheter during pump replacement.On (b)(6) 2017 the patient reported their pain was remarkedly improved since pump replacement.The entire system was explanted/replaced on (b)(6) 2017 and the device disposition was unknown.The outcome of the event resolved without sequelae on (b)(6) 2017.The device diagnosis was catheter occlusion and the clinical diagnosis was possible withdrawal symptoms.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 (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 patient's weight was (b)(6) pounds.The cause of the catheter occlusion was not determined.No further complications were reported/anticipated.

• 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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7241362
• MDR Text Key: 99047631
• Report Number: 3004209178-2018-02071
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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: 10/28/2012
• 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: 01/30/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/06/2018
• Date Device Manufactured: 05/02/2011
• 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: 71 YR
• Patient Weight: 79