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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Loss of Power (1475); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving dilaudid (1.0mg/ml at 0.1235mg/day) via intrathecal drug delivery pump.The indication for use was noted as spinal pain.It was reported that the patient's pump had "totally quit working." the patient went back in to the healthcare provider (hcp) because the lower part of her back started hurting again.She went to have a refill and told the nurse her back was really hurting again.The pump had been flipping over and they would have to flip t over to fill it.They were going to do a dye study but the hcp could not even get the dye in the pump.The patient said the hcp told her the pump totally shut down.The event date (b)(6) 2018 or (b)(6) 2018.There were no further complications reported at this time.

Manufacturer Narrative

Additional information indicated surgical intervention.- additional information indicated serious injury.- device code no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.It was reported that on 2018(b)(6) , the pump had to be flipped to perform a refill.On 2018 (b)(6), the pump had to be flipped to perform a refill.The expected volume was 8.1ml, but 17.5ml was withdrawn from the reservoir.On 2018 (b)(6) the catheter dye study was performed.They were unable to aspirate the fluid.Catheter occlusion was noted.Pump function was normal."totally quit working" was not the pump, but function of the catheter.Due to continued flipping, the hcp believed the catheter was occluded.There were no further complications reported at this time.

Manufacturer Narrative

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

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: 7686635
• MDR Text Key: 114039041
• Report Number: 3004209178-2018-15734
• 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: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• 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: 07/05/2017
• 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: 55 YR