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

Model Number 8637-40

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

Other relevant components include: product id: 8780, serial#: (b)(4), product type: catheter.Product id: 8784, serial#: (b)(4), product type: catheter.

Event Description

Information was received from a manufacturer representative regarding a consumer receiving gablofen [2000 mcg/ml] at a rate of 50 mcg/day via intrathecal drug delivery pump for intractable spasticity.It was reported that during a case the physician had difficulty with looping of the catheter in the intrathecal space which caused them to use a revision piece just by the way it was maneuvering it ended up where the needle was bent.The tip of the stylet was breaking off when he tried to remove it because he was going to try and thread the catheter without the stylet.The revision piece was used, anchored, and had good flow.Once the pump segment was connected and trying two separate collets, there was still poor flow when attempting to aspirate from the catheter access port (cap) and directly from the catheter on an empty syringe.They injected sterile saline through the catheter with a syringe and that flowed through.After they used a pump revision kit, they were still not getting good flow.They were never unable to aspirate 1-2 cc's from the catheter.The physician and resident speculated a collapse of the fecal sac or great resistance with a longer catheter.

Manufacturer Narrative

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: 6658294
• MDR Text Key: 78137604
• Report Number: 3004209178-2017-13463
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• 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 Age: 64 YR