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

Model Number 8637-40

Device Problems Filling Problem (1233); Battery Problem (2885)

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

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and post-spinal cord injury.The pump contained gablofen [2000 mcg/ml] at a dose of 200 mcg/day.It was reported during the procedure, they could not aspirate drug from the pump; there was no patient issue.There were no factors that might have led or contributed to the issue.They attempted with several different needles and even held pressure for several minutes thinking the reservoir valve might have sealed.Actions/interventions taken to resolve the issue included the drug was not aspirated, and new drug was obtained from the pharmacy.The pump was replaced on 2017-dec-21 and would be returned to the manufacturer for analysis.While attempting to aspirate the drug from the old pump, they were unable to do so despite numerous attempts.The issue was resolved at the time of the report.The patient¿s weight was unknown.The patient¿s status at the time of the report was alive ¿ no injury.No further patient complications were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The previously applied conclusion code is no longer applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a company representative.At the pump replacement surgery, regarding the inability to aspirate, the printout showed 8 cc were in the pump¿s reservoir.It was further noted that the battery was depleted.No rotor study was performed.The patient recovered without sequela.The pump was returned to the manufacturer for analysis.

Manufacturer Narrative

Analysis of the pump (sn; (b)(4)) found reservoir access issues due to residue occurred before internal decontamination.Destructive analysis identified residue in the drug flow path.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.

Event Description

Additional information was received via a company representative.Regarding the battery previously having been reported as being depleted, it was clarified that the pump was replaced due to normal battery depletion.No diagnostic tests were needed regarding the battery depletion and it was further noted that elective replacement indicator (eri) was one month.The patient did not experience any symptoms regarding the initial reason for pump replacement being due to normal battery depletion.

Manufacturer Narrative

The initial report indicated adverse event and product problem which is no longer applicable.This field is now updated to indicate product problem only.The initial report indicated that intervention was required to prevent permanent impairment/damage.Regarding additional information received 2018-jan-18.This is no longer applicable as it was clarified the pump was initially being replaced due to normal battery depletion.The initial report indicated the type of reportable event was a serious injury which is no longer applicable.The type of report is now a reportable malfunction.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7144018
• MDR Text Key: 95686943
• Report Number: 3004209178-2017-26609
• Device Sequence Number: 1
• Product Code: LKK
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2011
• 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: 57 YR