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); Material Split, Cut or Torn (4008)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 10/13/2022

Event Type  Injury  

Event Description

Information was received from a foreign healthcare provider (hcp) via a distributor regarding a patient receiving an unknown concentration of gabalon intrathecal at a daily dose rate of 15 mcg via an implantable pump for hereditary spastic paraplegia.Concomitant medications were none.The patient experienced back pain on (b)(6) 2022.When the patient was examined for discharge on (b)(6) 2022, the patient complained of back pain and a ct scan showed that the catheter tip had dropped 1 to 1.5 vertebral body.There appeared to be an anchor floating in the fluid that seemed to be cerebrospinal fluid (csf) leakage.An incision was made in the back on (b)(6) 2022, and the anchor was found to be partially detached and inverted vertically.The anchor was returned to its normal position and fixed again.The wound was closed.It was indicated that the anchor suture may have been dislodged and inverted for some reason, causing the fascia to be pulled back, which may have resulted in back pain.It was suspected that this may have also caused the catheter tip to drop.Regarding outcome of back pain, recovering as of (b)(6) 2022 was indicated.The relationship of the back pain to drug, catheter, and pump was unrelated.The relationship of the back pain to procedure was unknown.Additional information was received from a foreign healthcare provider (hcp) via a distributor on (b)(6) 2022.The patient¿s underlying disease was brain-derived spastic paresis; date of onset was 2017 (specific year known only).The female patient¿s height was 156 cm.Intrathecal baclofen implantation had occurred on (b)(6) 2022.Back pain on (b)(6) 2022 was indicated.As of (b)(6) 2022, swelling of the back wound, spinal fluid, anchor inversion, and catheter dislodgement was noted.The onset of the csf leakage was on (b)(6) 2022.A catheter x-ray was conducted on (b)(6) 2022, and abnormalities of anchor inversion and catheter dislodgment were noted.As of (b)(6) 2022, the patient experienced an increase in back swelling.Repair of csf leakage and anchoring was indicated.A repeat surgery on (b)(6) 2022 regarding reparation of anchor-fixed spinal fluid leakage was indicated.As of (b)(6) 2022, there was a reduction of csf leakage.Regarding anchor inversion, it was believed that the patient was affected by the rupture of the anchoring suture.It was further noted that the fact that they were a patient with ambulatory spastic paraplegia, subsequent catheter dislodgement occurred due to spinal fluid leakage accompanying this was observed.The spinal fluid leakage accumulated in the subfascial space, and pressure caused pain around the fascia.Re-anchoring of the anchor and catheter into the fascia in a total of 6 places occurred, in addition of a tobacco suture at the catheter insertion site were performed (local anesthesia surgery).Regarding the outcome of csf leak, recovering as of (b)(6) 2022 was indicated.The relationship of the csf leak to drug, catheter, and pump was unrelated.The relationship of the csf leak to procedure was unknown.Additional information was received from a foreign healthcare provider (hcp) via a distributor on (b)(6) 2022.The onset of the fluid leakage was on (b)(6) 2022.The patient required hospitalization or prolongation of hospitalization.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8781, serial#: (b)(4), ubd: 07-mar-2024, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15820609
• MDR Text Key: 303897992
• Report Number: 3004209178-2022-15236
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Date Device Manufactured: 02/09/2022
• 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; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 39 KG