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

Model Number 8637-20

Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8781 lot# n633900001 serial# implanted: (b)(6) 2017 explanted: product type catheter product id 8781 lot# n633900001 serial# implanted: (b)(6) 2017 explanted: 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 foreign healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving gabalon at an 0. 05% at 30 mcg/day in an intrathecal drug delivery pump for spinocerebellar degeneration (hereditary spastic paraplegia). It was reported that on (b)(6) 2017 a pump implantation was conducted from around 14:00 on the day. The catheter implantation site was th9 (reported as catheter replacement). The operation procedure was completed at 17:00 without any issues. It was noted that the higher position of the insertion location was th/l1 and the lower position as close to the lower end of the l1 spinal cord region. It was reported that the patient complained about foot pain, a pain in their little toes, around the pinky toe, and soles when they were back in their room. It was reported that the pain was l5/s1 pain in the lower left leg that started immediately after the first surgery. There was no reported paralysis. The patient was followed-up with until the next morning. The patient¿s pain was eased the next morning on (b)(6) 2017, however, the ¿pain observed repeatedly afterwards¿. The physician decided that the ¿patient to be followed up¿ until around 15:30 on monday. Initially, this pain was reported as not related to the investigational drug, catheter, pump and programmer but it was unknown if it was related to the surgical procedure. Further, the relationship to itb therapy was not thought to be strong because the patient already had a slipped, displacement, of the l5 vertebra before the surgery. Therefore, it was believed that the patient's posture during the surgery may have been related to the pain. It was reported that it was considered that the therapy was remotely related with the reported pain and on (b)(6) 2017 it was reported that this was related to the catheter and surgical procedure. Motor paralysis was not observed. The pain was temporarily improved by a l5/s1block. Since this was only temporary, epidural anesthesia was performed. As pain improvement was not observed, pressure due to the catheter at the cauda equina was suspected and catheter explant was conducted. Right after the procedure, the pain immediately disappeared. A spinal ct was done immediately after the surgery and a catheter was inserted from between th12/l1, but no particular spinal compression was discovered. So, it was decided that the epidural anesthesia would be carried out followed by observation. The physician assessment indicated the implant site was as high as th12/l1 and "conus medullaris was near lower end of conus medullaris. " it was further indicated that before catheter explant, the pain resolved due to opening up the "wounded area" with local anesthetic and loosening the anchoring device. The pain was considered to be a result of cauda equina nerve compression due to the catheter, rather than contact with the catheter. It was further stated another contributing factor was that the catheter was stiffer that the previous one. It was noted that the drug administration was discontinued on (b)(6) 2017. The event outcome was considered recovered as of (b)(6) 2017.

Manufacturer Narrative

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

Initially information was reported that it was further stated that another contributing factor was that the catheter was stiffer that the previous one. The information should have been reported as that it was further stated that another contributing factor was that the ascenda catheter was stiffer that the previous one.

• 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: 6326980
• MDR Text Key: 67282563
• Report Number: 3004209178-2017-03744
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/13/2017 Patient Sequence Number: 1