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

Model Number 8637-40

Device Problem Material Integrity Problem (2978)

Patient Problems Low Blood Pressure/ Hypotension (1914); Swelling (2091); Dizziness (2194)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-aug-10, information was received from a patient receiving bupivacaine (unknown dose and concentration) and baclofen (unknown dose and concentration, the patient stated she received 500 something then they were started back at 200) via an implantable pump for intractable spasticity. It was reported that the patient experienced complications after their pump was replaced on (b)(6) 2018. The patient reported that they were mis-diagnosed and it "took them a month to figure it out" and they were hospitalized twice before it was determined that it was related to their pump. The patient received a pump on (b)(6) 2018, and right after, they didn¿t feel right. On (b)(6) 2018, the pump site was swollen and the patient still wasn¿t feeling right. The patient stated they were very thin and the fluid was very noticeable. In the evening, the patient went to emergency room (er), however, the patient stated they didn¿t check the pump or give her anything and sent her home. The patient had an appointment on (b)(6) 2018 at the pain management clinic and stated that she was "real, real sick"; that their heart rate was 160 and blood pressure was really low. The patient stated they could "hardly think" and was really nauseous and they thought that she might have an infection. The patient stated that they thought she was having a stroke and they admitted her and called another hcp. The patient stated they were hospitalized until (b)(6) 2018 at 7 pm. The patient stated they would get dizzy all of the time and was passing out. The fluid was still building up at the pocket site. The patient went to their hcp on an unknown date to have the sutures removed and was told that the fluid would dissipate. The patient stated they quit using the bolus 7-10 days before the "27rd" because "she knew it wasn¿t delivering medication". On (b)(6) 2018, fluid was so big that the hcp called to escalate and was admitted that day. The patient received ct scan, blood draws and an ultra sound. The patient stated that they were on po baclofen and "norco" when hospitalized from the (b)(6). The patient was spasming really bad since "procedure". On (b)(6) 2018, the patient had a catheter revision. At the surgery, the patient was told there was a hole in the catheter where it meets the pump and as a result, the patient was not getting any medication. The patient was also told that 1000 cc of cerebrospinal fluid (csf) was withdrawn from the pocket and there was medication mixed in with it. The patient then reported they were told that they spliced the catheter and put it together. The patient was told that they weren't getting the medication and was going through baclofen withdrawal. The patient then stated that "by the time she had surgery, she believed that there were three pockets of fluid". The patient was discharged on (b)(6) 2018 and had an appointment for a nurse visit for (b)(6) 2018. The patient was scheduled for a refill on (b)(6) 2018. The situation was reported as resolved.

• 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: 7846598
• MDR Text Key: 119238043
• Report Number: 3004209178-2018-19907
• 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
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/28/2019
• 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: 08/10/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/02/2018
• 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: 09/05/2018 Patient Sequence Number: 1