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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial (b)(4), implanted: (b)(6) 2017, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot (b)(4), ubd: 26-jul-2019, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a consumer via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver dilaudid [20 mg/ml] at 6.001 mg/day and clonidine [250 mcg/ml] at 75.02 mcg/day.The indication for use was unknown.It was reported that the patient experienced a return of pain symptoms.The event occurred in 2018; the patient was unsure of exactly when she noticed, and it was stated ¿at least a month ago, maybe before that.¿ it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.It was noted that the patient mentioned having back surgery in (b)(6) 2018.It was reported that at a pump refill on (b)(6) 2018, a discrepancy of over 6 ml was noted.At the refill on (b)(6) 2018, 19 ml were removed when 6.6 ml had been expected.The patient had a myelogram on an unknown date, and the results reportedly showed the catheter tip in place.The patient presented for a dye study on (b)(6) 2018, and also scheduled a pump refill.It was reported that the physician could not aspirate from the cap and did not proceed with dye.The pump was filled and set to minimum rate.As an action/intervention taken to resolve the issue, the patient was referred for a catheter revision.The issue was not resolved at the time of the report.It was indicated that surgical intervention was planned but not yet scheduled.The patient's status at the time of the report was listed as ¿alive ¿ no injury.¿ no further complications were reported.The patient¿s medical history was asked but unknown.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a manufacturer's representative on 2018-jun-12.It was indicated that the provided information was confirmed with the physician/account.Additional clarification was provided regarding the volume discrepancy seen at pump refill on (b)(6) 2018.The actual reservoir volume was greater than expected.Per the hcp's information, 15 mls were removed, and 8.4 mls were expected.No further complications were reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 2018-jul-05 from the manufacturer's representative.It was reported that the patient was scheduled for a catheter revision on (b)(6) 2018.The indication for use of the device was non-malignant pain.No further complications were reported.

Manufacturer Narrative

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

• 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: 7587319
• MDR Text Key: 110627820
• Report Number: 3004209178-2018-13085
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,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: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 07/26/2017
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 79