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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problems Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/14/2021

Event Type  Injury  

Manufacturer Narrative

The event date is approximate.Other relevant device(s) are: product id 8596sc, lot/serial# (b)(4), implanted: (b)(6) 2009, product type catheter.Product id 8598, lot/serial# (b)(4), implanted: (b)(6) 2006, product type catheter.Product id: 8596sc, serial/lot #: (b)(4), ubd: 22-oct-2011, udi#: (b)(4).Product id: 8598, serial/lot #: (b)(4), ubd: 30-sep-2007, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative who was receiving baclofen, unknown (2000 mcg/ml at 1681 mcg) via an implantable pump for intractable spasticity and other spasticity.It was reported that the patient had been experiencing bad spasms in their legs, which started about 1 month earlier.About two weeks earlier the patient could not walk because of the spasms.The doctor increased  their dose 4-5x more than what he normally gets (per the patient) and the spasms got better, but at night, the patient still had spasms and was taking oral baclofen.The patient fell two months earlier, on their right side, where the pump was located.The physician was unable to aspirate during the dye study.The patient was being sent to a surgeon for a catheter revision.

• 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: 11689304
• MDR Text Key: 260692953
• Report Number: 3004209178-2021-06271
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Date Device Manufactured: 02/04/2016
• 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: 47 YR