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

Model Number 8637-40

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395)

Patient Problems Fever (1858); Muscular Rigidity (1968); Rash (2033); Therapeutic Response, Decreased (2271); Irritability (2421)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2007, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 16-oct-2008, udi#: (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) regarding a patient receiving unknown baclofen 2000 mcg/ml for a total dose of 389.7 mcg/day via an implantable pump.It was reported the hcp suspected that the catheter was disconnected from the pump and the patient was having withdrawal.It was reported the patient started having a rash and mild temperature.It was noted that the patient was more agitated and had increased spasticity.The hcp noted that the pump is perpendicular in the body.It was noted they were planning on replacing the pump tomorrow.The event date was (b)(6) 2020.No further complications were reported.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10043442
• MDR Text Key: 190511947
• Report Number: 3004209178-2020-08388
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2020

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: 06/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2020
• Initial Date FDA Received: 05/11/2020
• Date Device Manufactured: 01/10/2019
• 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