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

Model Number 8637-20

Device Problems Malposition of Device (2616); Difficult to Advance (2920)

Patient Problems Pain (1994); Numbness (2415)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; other relevant components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.A good faith effort will be made to obtain the applicable information relevant to the report.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 manufacturer¿s representative regarding a patient who was receiving dilaudid [1 mg/ml] at a dose of 0.1 mg/day via an implantable pump for non-malignant pain.It was reported the surgeon ran into an obstruction in the intrathecal (it) space while inserting the catheter during the implant on (b)(6) 2017.The patient experienced numbness in one leg and significant increased pain.It was asked but unknown if this was considered a sudden or gradual change in therapy/symptoms.Additional information was received from the hcp via a manufacturer¿s representative on 2017-apr-07.It was reported that the reported obstruction was nothing device related and was most likely anatomy.It was indicated that the target was top t11 but they ended up leaving the catheter at mid l1.It was stated ¿n/a¿ in response to actions/interventions taken to resolve the issue.It was indicated that the patient was admitted and observed as diagnostics related to the numbness in one leg and pain.It was noted that at day one post operation the patient was walking normally and reported a substantial decrease in leg pain.It was indicated that the numbness in one leg and significant increased pain had fully resolved and the cause was not determined.The representative did not know the patient's weight as it was not accessible to them.No further complications were reported or anticipated.

Manufacturer Narrative

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

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6477209
• MDR Text Key: 72284883
• Report Number: 3004209178-2017-07948
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2017

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: 07/28/2018
• 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: 03/23/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided; 04/18/2017
• Supplement Dates FDA Received: 04/18/2017; 10/03/2017
• Date Device Manufactured: 02/08/2017
• 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): Hospitalization
• Patient Age: 70 YR