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

Model Number 8637-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Respiratory Distress (2045); Dizziness (2194); Complaint, Ill-Defined (2331); Reaction (2414); Ambulation Difficulties (2544)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 2018-july-06, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving gablofen (2,000 mcg/ml, 177 mcg/day) via an implantable pump for intractable spasticity and post spinal cord injury.Since implant on (b)(6) 2017, the hcp has been titrating the patient's daily dose.The patient reported that each time there was a dose increase, their legs felt heavy and they were not able to do as much daily walking as normal.The hcp began troubleshooting the system on (b)(6) 2018.There were no reported environmental, external, or patient factors that may have led or contributed to the issue.X-rays appeared to be normal from "what can be visualized".Side-port aspiration was completed; 1 cc was aspirated from the catheter and priming bolus of the catheter only was programmed.It was stated, "after these procedures today, patient began to complain of dizziness, became hypotensive and went into respiratory distress.The patient was taken to the hospital where they were currently intubated and receiving medical assistance (respiratory support).The rep reviewed the programming strip with the hcp to ensure that only the catheter was primed during the side-port aspiration and no issues were seen on the programming strip.The issue was not resolved at the time of this report.No surgical intervention occurred nor was planned.The patient's status was alive - with injury.Note; the report title states, "side-port aspiration/possible overdose/jf" with no further mention of the term 'overdose' anywhere else in the report.

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, additional information was received from the healthcare professional (hcp) via the manufacturer representative (rep).The hcp went to the hospital to see the patient over the weekend and that they were doing better.The patient was extubated and medically stable.The hcp turned the patient from minimum rate back to their previous.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

The patient codes have been updated to include (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-aug-10, additional information was received from the healthcare professional (hcp).They reported overdose was not confirmed.The patient experienced an adverse effect of intrathecal baclofen medication.The cause of the patient's symptoms "adverse effect of intrathecal baclofen after reprogramming".The cause of the patient's heavy feeling legs and difficulty walking was "likely updated to increase intrathecal baclofen in system".The patient status was stable and they had recovered.

• 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: 7669961
• MDR Text Key: 113425340
• Report Number: 3004209178-2018-15259
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 08/22/2017
• 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; Required Intervention
• Patient Age: 64 YR