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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Sedation (2368); Loss of consciousness (2418); Lethargy (2560)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving gablofen 2000mcg/ml at 150mcg/day via an implantable pump.The indication for use was intractable spasticity.On (b)(6) 2019 it was reported that since the patient¿s first refill, the patient has been having episodes.The reporter stated that one refill they increased the medication from 130mcg/day to 150mcg/day and the same lot of medication had been in there since.Per the reporter, the patient¿s mother reported the patient has been having episode about every 10 days where she is sedated and unresponsive.The mom says these episodes last between a couple of hours to a couple of days and nothing seems to make it better, the patient eventually just comes out of it.They performed a dye study today and everything was normal, they looked at the rollers during the dye study and saw the rollers move 90 degrees.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

On 2019-mar-22, additional information was received from the healthcare professional (hcp).The hcp reported the cause of the symptoms has not been determined.The dose has been decreased from 150 mcg/day to 120 mcg/day.The pump was refilled early to asses actual volume compared to estimated volume.The pump was filled with 20 ml given the low daily dose.The next refill was scheduled for (b)(6) 2019.

Manufacturer Narrative

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

Event Description

On 2019-may-28, additional information was received from the healthcare professional (hcp).The hcp reported the cause of the patient's symptoms has not been determined.The hcp reported further actions taken; management coordinated with neurology: monitor for resolution of symptoms of hypotonia with itb pump at minimal rate and oral baclofen.Differential diagnosis includes autonomic failure per neurology.

Manufacturer Narrative

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

Event Description

On 2019-may-03, additional information was received from the healthcare professional (hcp).Additional information reported the refill was moved up to (b)(6) 2019 because the patient had a very long episode of lethargy and loss of tone following the dye and roller study on (b)(6) 2019.Upon interrogation of the patient's pump, estimated residual volume was 28.8 ml and logs showed no alarms or motor stalls.During the refill, approximately 29 ml of baclofen was aspirated.Patient's dose was decreased from 150 mcg/day to 120 mcg/day and she was refilled with 20 ml (not 40 ml).Of note, patient was monitored in the hospital with continuous eeg and an episode of lethargy/hypotonia was captured.Subsequently, pump rate was turned down to minimum rate; she has supplemental enteral baclofen.

• 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: 8377377
• MDR Text Key: 137366918
• Report Number: 3004209178-2019-04195
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• 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: 05/30/2019
• Date Device Manufactured: 02/15/2018
• 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): Other
• Patient Age: 12 YR
• Patient Weight: 34