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

Model Number 8637-40

Device Problems Filling Problem (1233); Obstruction of Flow (2423); Protective Measures Problem (3015); Insufficient Information (3190)

Patient Problems Seizures (2063); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444); Shaking/Tremors (2515); Sleep Dysfunction (2517)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter. Product id: 85 96sc, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter. Product id: 8709, serial/lot #: (b)(4), ubd: 15-aug-2013, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 03-nov-2013, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

On 2020-mar-06, information was received from a family member of a patient receiving baclofen (2,000 mcg/ml, 619. 1 mcg/day) via an implantable pump for intractable spasticity. It was reported the pump seemed to be working, but something was wrong. The caller reported the patient was tremoring once or twice in maybe the past 6 months or so, but she did not associate it with the pump. They were very slight and isolated occurrences, but last week, they became pronounced and ongoing. Last week, the patient had severe withdrawal. The caller initially thought the patient was having a seizure. The patient went to the emergency room (er). After a couple of nights of hospital stay, they thought the pump was working, but "suspect something [was] wrong in terms of connection". They did x-rays and the caller heard the healthcare professional (hcp) say something was blocking the catheter. The caller stated it was "something about catheter in the hub". They told her it was difficult to see the "connection" inside of the pump, it would not show on the x-ray. They "bolused' the catheter and caller thought the bolus actually unblocked whatever blockage the catheter was having. The patient seemed to be okay and went home, but after she came home, the patient still had been showing withdrawal symptoms (legs were jumpy, sweaty, shaking, tremoring). The caller stated, "this is week # 2 now". They were supplementing baclofen orally with a pill. The caller mentioned the pump was replaced in 2018, due to normal battery depletion but the catheter was not replaced, it was about 10 years old. The caller stated there was no alarm, but the patient has cerebral palsy and was non-verbal and could not tell if she heard any alarms. It was noted that when providing the drug information, the caller also read 25. 8 mcg/hour. The patient was on the same mediation as 6 months ago. The caller stated they have been grateful for the pump and it has been working beautiful until symptoms became ongoing last week.

Manufacturer Narrative

Product id: 8709, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter; product id: 85 96sc, serial# (b)(4), implanted: (b)(6) 2012. Product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer on 2020-jul-09. It was reported that the patient is in a wheelchair and have convulsion at night. The hcp has done several tests and he would like to know what the options are for the patient, maybe the pump/catheter will need to be removed. Caller states patient takes oral baclofen which helps patient symptoms. Technical (ts) and patient services (ps) conferenced with the caller and discussed pertinent information regarding options for discontinuing therapy and reviewed having this conversation with the managing physician. Ts reviewed pump/catheter functions. Ts/ps recommend caller consult with the hcp office and call ts if necessary, or consult with a local rep. There were no further complications reported/anticipated.

• 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: 9806862
• MDR Text Key: 196398384
• Report Number: 3004209178-2020-04962
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/09/2020 Patient Sequence Number: 1