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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Ingredient or Reagent Problem (2910); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving baclofen 2000 mcg/ml; unknown dose via an implantable pump.Indication for use was intractable spasticity and cerebral palsy.The date of the event was (b)(6) 2017.It was reported the patient experienced an increase in leg spasticity over the last two days.On (b)(6) 2017 the pump had a volume discrepancy.The actual residual volume (arv) of 8 was greater than the expected residual volume (erv) of 3.3.At the end of the aspiration from the refill port the hcp got back some blood tinged drug.The hcp was certain she was in the port.The pump was shallow and had no swelling.No further complications were reported.Additional information was received from a healthcare professional (hcp).The cause of the volume discrepancy was unknown.Actions included monitoring with each refill; consist of 8 ml of medication fluid removed regardless of the low reservoir reading past 1 year.The volume discrepancy and increased spasticity have not been resolved.The volume discrepancy will be monitored, and spasticity will be treated and monitored.The spasticity only recently reported with the last refill; started two days prior to refill.The patient¿s weight at the time of the event was (b)(6).The patient has been stable without issues.Additional information was received from saol.The baclofen was clarified to be lioresal.The patient was identified as caucasian.Additional medical history included spastic paraplegia.Concomitant medications included a cranberry supplement, calcium with vitamin d3, vitamin b-12, diclofenac, famotidine, melatonin,polyethylene glycol, promethazine, rizatriptan and vesicare (solifenacin succinate).Dates of therapies, routes, dosages and frequencies of use were not reported.On (b)(6) 2016, the patient started treatment with lioresal 2000 g/ml at 807g/day, intrathecally via the pump, for spasticity, spastic paraplegia and cerebral palsy.It was further specified the increase inleg spasticity was on the left side.It was clarified that during the refill procedure, the needle was changed and no blood was pushed into the pump.The patient was monitored via phone and as of (b)(6) 2017, no issues were reported.Additional information was received from a health care provider (hcp) via a device manufacturer representative on (b)(6) 2018.It was reported that the volume discrepancies had continued and were increasing in volume.It was also noted the doctor had been increasing the patient's dosages without efficacy regarding symptom relief.The following discrepancies were reported by the doctor: in (b)(6) 2017 erv=8ml, arv=8.5ml; in (b)(6) 2017 erv=6.2ml, arv=8ml; in (b)(6) 2017 erv=4.3ml, arv=8ml; on (b)(6) 2017 erv=3.3ml, arv=8ml; on (b)(6) 2018 erv=3.3ml, arv=10ml; on (b)(6) 2018 erv-2.3ml, arv=11ml.There were no environmental, external or patient factors which may have led or contributed to the issue.No diagnostics had been performed at the time of the report.The issue was not considered resolved.No further complications were reported.

Manufacturer Narrative

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

Event Description

On 2018-may-17, additional information was received from a healthcare professional (hcp).The hcp reported the cause of the increasing volume discrepancies was unknown.The hcp reported they would continue monitoring the issue and indicated that there would be future testing for patency of the catheter/pump.The patient's dye study was "tbs - (to be scheduled)".

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 a manufacturer representative (rep).Additional volume discrepancies were reported.On (b)(6) 2018, the expected reservoir volume (erv) was 4.5 ml, the actual reservoir volume (arv) was 11.3 ml.A dye study was scheduled for (b)(6) 2018.The issue was not resolved at the time of this report.

• 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: 7515113
• MDR Text Key: 108364268
• Report Number: 3004209178-2018-10942
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2018
• Date Device Manufactured: 04/05/2016
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 52