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

Model Number 8637-40

Device Problem Intermittent Infusion (2341)

Patient Problems Twitching (2172); Dizziness (2194); Therapeutic Response, Decreased (2271); Anxiety (2328); Sleep Dysfunction (2517); Alteration In Body Temperature (2682)

Event Date 07/01/2018

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 (hcp) via a manufacturing representative (rep) regarding a patient receiving 20 mg/ml of morphine at 9.003 mg/day via an implantable pump for non-malignant pain and postlaminectomy pain.It was reported a motor stall was seen upon interrogation.The patient had not had a magnetic resonance imaging procedure (mri) recently.The logs indicated a motor stall occurred (b)(6) 2018 at 08:58 and recovered on (b)(6) 2018 at 13:23.A second motor stall occurred (b)(6) 2018 at 19:07.The motor stall was active (not recovered).Electromagnetic interference (emi) considerations were reviewed.It was confirmed there were no emi/magnetic sources present.It was reviewed to consider programming the pump to minimum rate mode and covering the patient with non-pump medication.The patient reported feeling light headed, jittery, hot/cold, and their jaw started twitching and could not be stopped.It was reported the patient was going into withdrawals.The symptoms began around 4am the day of the report ((b)(6) 2018).It was reported the symptoms began gradually.The alarm began beeping around 11:00 the day before ((b)(6) 2018) and the pump was alarming every 20 minutes.The patient¿s personal therapy manager (ptm) also showed the code 8476 (motor stall).The patient reported they had a difficult time going to sleep the night before.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer¿s representative (rep) on 2018-jul-23.It was reported that the pump was replaced on 2018-(b)(6).It was also indicated that the cause of the motor stall was unknown.The pump would not be returned for analysis, as the pump was replaced and discarded.The patient¿s weight at the time of the event was unknown.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Adverse event or problem and type of event have been updated.The evaluation codes have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer 2018-jul-20.The patient reported they were supposed to have surgery (b)(6) 2018 but it was postponed until (b)(6) 2018.The patient had not received any information.It was reported the alarm that was going off was loud and they could not sleep.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7663960
• MDR Text Key: 113301383
• Report Number: 3004209178-2018-15048
• Device Sequence Number: 1
• Product Code: LKK
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/20/2018; 07/23/2018; 08/08/2018
• Supplement Dates FDA Received: 07/24/2018; 07/25/2018; 10/03/2018
• Date Device Manufactured: 11/26/2012
• 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): Required Intervention
• Patient Age: 59 YR