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

Model Number 8637-40

Device Problems Disconnection (1171); Filling Problem (1233); Difficult to Interrogate (1331); Unstable (1667); Positioning Problem (3009)

Patient Problems Swelling (2091); Fluid Discharge (2686); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 1 mg/ml morphine at 0.7002 mg/day via an implantable pump for non-malignant pain.It was reported that there was a telemetry problem with the pump on (b)(6) 2017.It was noted that sources of emi, specified as computers and x-ray equipment, were present, however moving away from these sources did not resolve the issue.The patient was in for their first refill since implant in june and the hcp was trying to verify the pump location via x-ray as they were having difficulty palpating the pump area to locate the pump.It was further stated that they were having trouble feeling where the pump was.No symptoms were reported.It was later reported that the hcp was able to establish telemetry.Landmarks related to a flipped pump were asked about and the patient was then diagnosed with a flipped pump.The date the pump flipped was unknown.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).The patient saw a neurosurgeon and he manually unflipped the pump.There was no telemetry problem.After the pump was unflipped, the hcp was able to successfully fill the pump.The cause of the flipped pump was noted to be patient anatomy.The event was resolved.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a manufacturer representative (rep) on 2017-sep-06 reported a flipped pump was confirmed.It was noted that the patient had a refill attempted, but the hcp was unable to access the reservoir septum.The hcp considered a flipped pump and x-rays were performed and confirmed the pump was flipped.Per rep, an anterior-posterior (ap) x-ray confirmed the pump was flipped.Rep will follow up with hcp.Event date was unknown.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received on 2018-jan-26 from a health care provider (hcp) reported there had been a history of pump issues with the patient.The hcp stated in (b)(6) 2017, there was a pump flipping issue.Also, in (b)(6) 2017, the patient¿s stomach was swelling, and fluid was leaking out.The hcp reported they determined the pump was placed in the pocket area too deep, so they repositioned the pump higher up in the pocket area closer to the patient¿s abdomen.No further patient complications were reported.

Manufacturer Narrative

The other relevant components include: product id 8780 lot# (b)(4) implanted: (b)(6) 2017 explanted: product type catheter product id 8784 lot# (b)(4) implanted: (b)(6) 2017 explanted: product type catheter.Device code (b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the hcp on 2018-jan-31.It was reported that the ¿pump was not too deep.¿ it was also reported that the cause of the pump placement issue was determined to be ¿catheter disconnected from pump; unclear reason.¿ there were no further complications reported/anticipated.

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: 6842137
• MDR Text Key: 84960107
• Report Number: 3004209178-2017-18716
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• 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: 01/31/2018
• Date Device Manufactured: 02/09/2017
• 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: 51 YR