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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

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

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Product id: 8780, serial/lot #: (b)(4), ubd: 03-mar-2019, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a healthcare provider (hcp) via a manufacturer¿s representative (rep) regarding an implantable intrathecal pump intended to deliver prialt (concentration and dose unknown), indicated for spinal pain.On 2018-jun-26, it was reported that there was a volume discrepancy where the actual reservoir volume (arv) was greater than the expected reservoir volume (erv).The pump was implanted on (b)(6) 2017.The patient came into the office for a prialt exchange on (b)(6) 2017 at which time no reservoir discrepancies were noted.At the next refill on (b)(6) 2017, interrogation of the pump revealed an erv of 4.8 ml, however 7.1 ml were withdrawn.It was reported that from this point, the reservoir volume discrepancies increased.At the refill on (b)(6) 2018, the erv was 2.8 ml and the volume withdrawn was 18.8 ml.At the refill on (b)(6) 2018, the erv was 4 ml and the volume withdrawn was 19 ml.It was reported that following this, the patient had a catheter revision on (b)(6) 2018.The revision revealed multiple occlusions that were corrected from the pump to the intrathecal space insertion site.No patient symptoms 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: 7647553
• MDR Text Key: 112703751
• Report Number: 3004209178-2018-14595
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• 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: 06/26/2018
• Date Device Manufactured: 07/13/2017
• 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: 46 YR