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

Model Number 8637-20

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Constipation (3274)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter, product id: 8784, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4); product id: 8784, serial/lot #: (b)(4), (b)(6), (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 manufacturer representative (rep) regarding a patient who was receiving gablofen, 1000 mcg/ml concentration at 115 mcg/day dose via intrathecal drug delivery pump for intractable spasticity and cerebral palsy.It was reported that patient started exhibiting increased tone and itching on (b)(6) 2018 and parents brought her into the clinic to be evaluated.The hcps accessed catheter access port (cap) and were easily able to withdraw cerebrospinal fluid (csf), so they sent home with oral baclofen.Increased tone and itching improved; on (b)(6) she started exhibiting increased tone and itching again; brought into hospital.Pump log interrogations within normal limits.Patient evacuated of large constipated stool and given tranxene; symptoms once again improved.Computed tomography (ct) dye study was planned on (b)(6) 2018; after three attempts, they were unable to aspirate fluid from cap so surgery was planned for catheter replacement on (b)(6) 2018.Existing catheters were explanted and replaced with a new 8780.Upon disconnecting existing catheter from existing pump, no spontaneous retrograde flow csf was observed.No environmental/external/patient factors that may have led or contributed to the issue were reported.At the time of this report, the issue was resolved and patient status was alive- no injury.The patient¿s medical history included spastic quadriplegic, cerebral palsy, gmfcs iii, dm type 1 with insulin pump.The patient¿s concomitant medications included zyrtec, flonase, insulin, miralax and senna.Inf usion rate was re-started at 100 mcg/day after catheter was replaced.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via the manufacturer representative (rep).It was reported that cause of inability to aspirate the catheter was never determined.The catheter had been returned and tracking number was reported.It was shipped out saturday.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 8780, (b)(4), implanted: (b)(6) 2012, explanted: (b)(6)2018, product type: catheter, product id: 8784, (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter; product id: 8784, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.The catheters, 8780 and 8784, were returned.For 8780, analysis found catheter/miscellaneous/acceptable testing/catheter incomplete/returned in segments.For 8784, analysis found catheter kink and damage to the transition tube.(b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 7655921
• MDR Text Key: 112935573
• Report Number: 3004209178-2018-14809
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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: 10 YR
• Patient Weight: 35