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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problems Headache (1880); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot (b)(4), ubd: 02-dec-2018, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient who was receiving gablofen (2000 mcg/ml at a dosage of 494.7) via an implantable infusion pump for intractable spasticity and cerebral palsy.It was reported that the patient complained of increased lower extremity tone, headaches, nausea, and vomiting, which were consistent with intrathecal baclofen withdrawal symptoms.Contractures were also noted.The withdrawal symptoms started five days prior to (b)(6) 2018.The patient had similar symptoms in (b)(6) 2018.The symptoms improved after side port aspiration.There was concern that a small obstruction was dislodged.There were no environmental/external/patient factors reported that may have led or contributed to the issue.The catheter was replaced due to the withdrawal symptoms.The issue was resolved at the time of the report.The patient's status at the time of the report was alive - no injury.No further complications were reported.

Manufacturer Narrative

The catheter was returned in segments, and analysis found acceptable testing.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: 7634352
• MDR Text Key: 112195721
• Report Number: 3004209178-2018-14215
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 53