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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Data Problem (3196)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/13/2017

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 healthcare professional (hcp) via a company representative regarding a patient who was receiving an unknown medication via an implantable pump.Indication for use was non-malignant pain and failed back surgery syndrome.Other medications the patient was taking at time of the event were not available.The date of the event was (b)(6) 2017.It was reported the patient experienced withdrawal.The pump was beeping.The pump was interrogated and was in safe mode; premature elective replacement indicator (eri) had occurred.The pump was being replaced (b)(6) 2017.The issue was not resolved.No environmental/external/patient factors may have led or contributed to the issue.Patient weight and medical history were asked and will not be made available.Patient status at time of this report was alive -no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a company representative.The cause of the elective replacement indicator (eri) was unknown.The pump was replaced.The patient is out of medication withdrawal and doing well.The removed pump will not be sent back for analysis as is against the hospitals protocol.

• 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: 7128056
• MDR Text Key: 95184988
• Report Number: 3004209178-2017-26240
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

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: 05/14/2012
• 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: 12/14/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 01/03/2018
• Date Device Manufactured: 11/19/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR