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

Model Number 8637-20

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider on (b)(6) 2017 regarding a patient's implanted infusion pump containing clonidine (2000mcg/ml at 119.8mcg/day) and unknown baclofen (1000mcg/ml at 59.9mcg/day).The indication for use was intractable spasticity.It was reported that the patient underwent magnetic resonance imaging (mri) for a reason unrelated to the device or therapy on (b)(6) 2017 at 11:00am.A motor stall occurred at 11:20am, and had not recovered by 02:21pm.It was reviewed that the pump should continue to be checked for recovery, and it was recommended that the patient be medically managed if necessary.No patient symptoms were reported, and no further complications were reported or anticipated.

Manufacturer Narrative

(b)(4) no longer applies.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider on 2017-mar-30.It was reported that 5 hours after the mri, the pump still had not recovered.The patient had no symptoms of withdrawal.The pump was interrogated multiple times, and the patient was managed medically.On (b)(6) 2017, the motor stall was noted to have recovered within 24 hours of the stall.The situation was considered resolved.

Manufacturer Narrative

Corrected information: sex, date of birth.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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6443061
• MDR Text Key: 71234730
• Report Number: 3004209178-2017-06597
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0591-2009
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 52