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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

Patient Problems Muscular Rigidity (1968); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving baclofen (2,000 mcg/ml, 313 mcg/day) from an implantable pump for intractable spasticity.On (b)(6) 2018, the patient had an magnetic resonance imaging (mri) performed due to lower extremity osteomyelitis.A motor stall was seen on initial interrogation.Logs were inspected and a motor stall recovery has not occurred.It was noted that the patient left the mri field more than two hours prior.Additional information was provided that indicated the pump stall had recovered (date not provided).The actions taken to resolve the event were; pump interrogation and medication management.The reported cause of the stall was the mri.It was also noted that the patient did present with spasticity a couple times since the mri.The dates were (b)(6) 2018.It was noted that they presented to the emergency department (ed) "primary for other indications, with secondary complaints of spasticity".Discrepant information was received from the rep that stated the mri occurred and stall occurred on "(b)(6)".Follow up is being performed to clarify the discrepancy.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(4) 2018, additional information was received from the rep.The rep clarified that the correct date for the motor stall and mri was (b)(4) 2018.The rep also reported that the 'other indications' the patient presented to the emergency room were related to osteomyelitis.

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: 7739684
• MDR Text Key: 116259880
• Report Number: 3004209178-2018-17156
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• 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: 08/08/2018
• Date Device Manufactured: 10/23/2014
• 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: 78 YR