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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received via a manufacturer representative (rep) from a patient who was receiving unknown drug, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain.It was reported that the patient said her pump flipped in the pocket.She had not noticed any change in drug delivery but there was clearly a risk of that happening.No environmental/external/patient factors were reported.Diagnostics/troubleshooting performed were not applicable.Pocket revision was scheduled for today.Surgical intervention was scheduled on (b)(6) 2018.At the time of this report, the issue was not resolved and patient status was alive- no injury.The patient¿s medical history included degenerative disc disease, osteoporosis and multiple back operations.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 (rep).It was reported that the patient had loose fatty tissue and the pump suturing lost hold in the pocket.The hcp collapsed the capsule more and tacked the pump down with multiple sutures at each corner of the pump.The pump flip had been resolved.The device was implanted and active.No further complications were reported.

Manufacturer Narrative

The catheter was returned and analysis found the catheter body had damage to the transition tube.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.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-feb-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Catheter was returned and it was reported that pump segment of the catheter was reused when the healthcare provider (hcp) noticed a tear in the catheter.No further complication was 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: 7704475
• MDR Text Key: 114501687
• Report Number: 3004209178-2018-16228
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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: 64 YR
• Patient Weight: 75