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

Model Number 8637-20

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

Patient Problems Hyperthermia (1909); Low Blood Pressure/ Hypotension (1914); Hypothermia (1915); Loss of consciousness (2418); Cognitive Changes (2551); Convulsion/Seizure (4406); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (manufacturer representative, friend/family member) regarding a patient who was receiving baclofen (unknown) (500.8 mcg/ml at 154.15 mcg/day) via an implantable pump for intractable spasticity and cerebral palsy.It was reported that the patient was implanted on thursday ((b)(6) 2021) and by sunday around 12:30pm, the caller stated the patient was showing symptoms of baclofen toxicity and confirmed overdose showing hyperthermia, not alert, unresponsive, seizures and was in the icu due to hyperthermia.The patient had flex dosing which delivered a bolus approximately 12:30pm on sunday.  on sunday ((b)(6) 2021), they decreased the dose and updated the pump at that time.  they were trying to figure out what happened with the pump that day, however the pump records had been deleted for that time stamp.The patient was currently on flex dosing, and they wanted to see what the flex dosing was at the time.  they had a 22.98 mcg bolus at 8am and 12noon (5 minute bolus duration).  the time of the event, which was 12:30pm on sunday ((b)(6) 2021 was "accidentally" deleted by error by the pa.  the caller was wondering if there was a way to get those records back.Information inquiries were reviewed.  the caller stated the patient was currently able to maintain her temperature now that there were 3-4 days since the event.  they were not expecting any permanent damage.  the patient was doing much better.  troubleshooting was not required.  the issue was not resolved through troubleshooting.The caller was redirected to their hcp to further address the issue.The manufacturer representative (rep) called in and asked if a report was deleted on the tablet, is there any way to get the information.  the information inquiry was reviewed.Additional information was received when the patient's mother called and gave more information around the symptoms the patient had at the time of the event.  hypothermia, hypotension, unresponsive, no tone.  the patient was doing better now.  at the time of the event, temperature was so low they could not get a reading.Program log inquiries were reviewed.

• 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: 11845077
• MDR Text Key: 262655454
• Report Number: 3004209178-2021-07916
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/18/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/18/2021
• Date Device Manufactured: 01/27/2021
• 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): Hospitalization; Life Threatening
• Patient Age: 14 YR