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

Model Number 8637-40

Device Problem Occlusion Within Device (1423)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8596sc, serial (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8596sc, serial/lot (b)(4), ubd: 14-may-2011, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 2000 mcg/ml baclofen at 1075 mcg/day via an implantable infusion pump for intractable spasticity and cerebral palsy.It was reported that the patient presented with withdrawal symptoms.It was reported the dose had been increased since the original implant.The hcp decided to replace the entire system.It was reported that the entire system was explanted on (b)(6) 2018.Upon the removal the catheter tip appeared to be occluded, but it was not tested.The catheter appeared to flow when cut.It was reported that the patient was not involved in a clinical study.It was reported the device would be returned to the manufacturer, and the device was replaced with a manufacturer's product.It was reported that the device was used with/in the patient for treatment.There was no patient death or injury, and the patient recovered without sequela.No rotor study or dye study was performed and the pump was explanted due to a therapy related issue.No further complications were anticipated/reported.

Manufacturer Narrative

Analysis of the pump found no anomalies.Analysis of the suture less connector catheter found coring-tears-cuts in the seal that meets the leak criteria.Analysis of the (b)(4) catheter found no significant anomaly (it was returned in segments).Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code (b)(4) because, although the device was operating within specifications, medtronic modified the specifications making this the closest code available with respect to this event.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: 7414148
• MDR Text Key: 104934183
• Report Number: 3004209178-2018-07013
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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: 06/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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: 31 YR