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

Model Number 8637-40

Device Problems Unstable (1667); Material Integrity Problem (2978); Torn Material (3024)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8780, serial (b)(4), implanted: (b)(6) 2017, product type: catheter.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 morphine 5.5 mg ml; 0.5 mg day via an implantable pump.Indication for use was non-malignant pain.Other medications the patient was taking at time of the event were not available.Patient weight and medical history were unknown.The date of the event was (b)(6) 2017.It was reported the hcp attempted to refill the pump several days ago and was unable to locate the reservoir opening.The hcp was unable to refill pump.The hcp rescheduled a refill at the hospital under fluoroscopy on (b)(6) 2017.Fluoroscopy revealed a flipped pump and the catheter appeared to be twisted a pump revision and possible catheter revision were scheduled for (b)(6) 2017.The pump will be relocated to the right flank.No symptoms were reported.There were no known environmental/external/patient factors that may have led or contributed to the issue.The issue was not resolved.Patient status at time of this report was alive - no injury.No further complications were reported.

Manufacturer Narrative

Section d references the main component of the device system; the other relevant components include: product id 8780 lot# serial# (b)(4) implanted: 2017 (b)(6) explanted: 2017 (b)(6) product type catheter product id 8780 lot# serial# (b)(4) implanted: 2017 (b)(6) explanted: 2017 (b)(6) product type catheter: device code (b)(4) and patient code (b)(4) no longer apply.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 manufacturer representative on 2017-dec-15.X-rays and a dye study were performed.It was reported that the patient experienced a loss of relief from the pump on an unspecified date.Surgery to revise the pump and catheter occurred on 2017 (b)(6), and revealed that the catheter was badly twisted.It was further noted that all four suture ties were broken, allowing the pump to flip in the pocket.The twisted catheter (65mm) was carefully removed and replaced with a new piece, and the pump was relocated to a new pocket in the right posterior abdomen.An old catheter that was no longer in use and no longer intrathecal was also removed.It was noted that the patient had some minor falls that may have contributed to the event as well as weight gain and loss.The issue was considered resolved at the time of report, and the patient's status was alive - no injury.The pump was infusing morphine (5mg/ml at 0.25mg/day) at the time of report.

• 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: 7075031
• MDR Text Key: 93470447
• Report Number: 3004209178-2017-24691
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• 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: 12/15/2017
• Date Device Manufactured: 07/08/2016
• 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: 69 YR
• Patient Weight: 111