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); Suction Problem (2170); Infusion or Flow Problem (2964); Positioning Problem (3009)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 07-dec-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving dilaudid (0.224 mg/day reduced to 0.1 mg/day, 1 mg/ml) via an implantable pump for non-malignant pain.On (b)(6) 2018, the patient was not getting any relief so their daily dose was increased (unknown increase).A roller study was performed and they could not aspirate the catheter.It was stated, "expected volume was in reservoir".Under fluoroscopy, there were no apparent kinks nor disconnections.The patient was told they needed to "go back in and explore catheter positioning".The issue was not resolved at the time of this report.The patient's status was alive - no injury.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2018, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a device manufacturer representative indicated that the patient was receiving dilaudid (1 m g/ml at.048 mg/day) via an implantable infusion pump.It was reported that the patient did not feel like the pain was getting better after each pump adjustment.The healthcare provider (hcp) attempted a dye study and was unable to get cerebrospinal fluid back.It was unknown if any environmental/external/patient factors led or contributed to the issue.The spinal segment of the catheter was replaced and the issue was reported to be resolved.The patient was noted to be alive with no injury.No further complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, additional information was received from an healthcare professional (hcp).Additional information reported that the dose increase was from 0.1682 to 0.2188 mg/day.The catheter tip was explanted and replaced.No analysis was requested as it was a "suspected placement issue".The cause of the lack of efficacy was "catheter placement not intrathecal".The patient has recovered from the event.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacture's representative reported no roller study was performed.It was stated that no exploratory surgery for catheter positioning occurred.No further information.

• 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: 7711043
• MDR Text Key: 114735756
• Report Number: 3004209178-2018-16390
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 10/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 08/20/2018; 09/11/2018; 08/08/2018
• Supplement Dates FDA Received: 07/31/2018; 08/21/2018; 09/13/2018; 10/04/2018
• Date Device Manufactured: 04/25/2018
• 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: 43 YR
• Patient Weight: 78