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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# (b)(4), product type: programmer, physician.Other relevant device(s) are: product id: 8840, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient receiving hydromorphone 6mg/ml at 0.5mg/day via an implantable pump.The indication for use was spinal pain.On (b)(6) 2019 the healthcare provider reported that they made programming changes but when trying to update the pump it got stuck at 45%.The healthcare provider utilized both the tablet and the 8840 and was able to perform telemetry to begin with but unable to establish telemetry and pump memory error with stopped pump occurred while trying to update the pump.Device troubleshooting was performed but the healthcare provider was not successful with programming and updating the patient¿s pump.The healthcare provider tried a lead apron, repositioning the programming head directly over the pump antenna, turning off the lights, moving the patient to a different location within the clinic twice, laying the patient down on the examining table and sitting them up, removing emi in the environment with no mobile mri unit in the area.The healthcare provider did not have any tin foil to try that over the pump and programming head.The patient was not in a motorized wheelchair.The healthcare provider also stated the pump is a little tilted in patient¿s body and the patient is thick/bigger in size but this was the first time they have had these issues with this patient¿s pump.The healthcare provider also tried repositioning the programming head at different angles along with pressing on to the pump and bringing the programming head about 1/2 inch up from the pump with no success of updating the pump.The healthcare provider stated they were able to do a pump refill earlier today with no issues.The healthcare provider would have the patient go to lunch and cover the patient with oral meds as the pump was in stopped pump mode.The patient was to return to the clinic this afternoon and the healthcare provider would try and update the patient¿s pump at that time.Additional information was received the same day from the healthcare provider who reported that they tried again this afternoon and still could not telemetry/update the patient's pump so the physician sent the patient home with emergency po drugs.Per the healthcare provider the patient boluses 3 times a day with the ptm and the patient did not state she wasn't able to do that as the patient was usually very verbal if she was experiencing pain/therapy issues.Today the patient was doing well with the pump therapy.The healthcare provider did not know if the patient had any medical procedures like radiation treatment, etc.That could have caused this pump issue.The physician would decide to possibly call the surgeon to let them know and maybe replace the patient¿s pump.No patient symptoms and 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 on 01-jul-2019 from a healthcare professional (hcp) who reported that the cause for the difficult communication with patient¿s ptm (personal therapy manager) was not determined.No further complications have been reported as a result of this event.

Manufacturer Narrative

Product problem, outcome, and event type have been updated.The evaluation code method has been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider (hcp) via the manufacturing representative (rep).It was reported the pump was replaced on (b)(6) 2019 and would be returned to the manufacturer for analysis.The rep stated the pump could not be updated after a refill and the patient did not have any known factors that contributed to the issue.The rep stated that the device could be interrogated but could not be updated, both in the office and meeting with the sales rep.Troubleshooting was attempted, as previously reported.The issue was resolved at the time of the report, (b)(6) 2019.The patient's status was provided as alive - no injury.The patient's medical history included smoking.

Manufacturer Narrative

Analysis of the pump revealed pump hybrid bit flip; in telemetry handler memory.This device issue is known and documented in the labeling per (b)(4)¿ n¿vision clinician programmer with software synchromed ii infusion systems.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the company representative on 20-jun-2019 who stated they were currently with the patient and could interrogate the pump without difficulty.The alerts showed 99, 102, 140 with verbiage of loss of therapy, pump stopped due to temporary stop command, previous update unsuccessful, pump memory error pa settings not available.They switched to the 8840 clinician programmer and attempted to enable pa dosing, simple continuous dosing and alarm interval change.The update was still only in progress at 40-50 %.They attempted a therapy stop and this was also unsuccessful.They also went to all fields and made changes to see if they could update successfully and they were still unsuccessful.No further complications were reported or anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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
• MDR Report Key: 8707537
• MDR Text Key: 148291345
• Report Number: 3004209178-2019-11788
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 102