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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Device Or Device Fragments Location Unknown (2590); Aspiration Issue (2883)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8731, serial# (b)(4), implanted: (b)(6) 2004, product type catheter; product id: 8731, serial/lot #: (b)(4), ubd: (b)(6) 2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a device manufacturer representative regarding a patient who was receiving an unknown drug via an implantable infusion pump for spinal pain, non-malignant pain, and other non-malignant pain.It was reported that there had been a reservoir volume discrepancy where they aspirated the same amount of drug at the pump refill that was placed in the pump at the previous refill.The patient was also experiencing withdrawal.The event date was asked but unknown.The hcp suspected a kink in the catheter.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 healthcare professional (hcp) via a manufacturer representative.They went in to look at the catheter but were not able to aspirate.The hcp tied off the old catheter and left it in the patient and added a new one.

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.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the hcp said the patient was doing fine after the surgery.No further complications were reported.

• 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: 7532085
• MDR Text Key: 108897469
• Report Number: 3004209178-2018-11453
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Date Device Manufactured: 01/22/2018
• 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