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

Model Number 8637-20

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Abdominal Pain (1685); Cerebrospinal Fluid Leakage (1772); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Pain (1994); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8711, lot# j11465r14, implanted: (b)(6) 2003-, product type: catheter.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 consumer (con) regarding a patient receiving baclofen of an unknown concentration at an unknown dose via an implantable infusion pump for movement disorder.It was reported that the patient was having severe abdominal, side port and rib pain around their pump area.The patient's doctor was unable to find the patient's side port (catheter access port).Additional information was received from the healthcare provider (hcp) via the return paperwork.The pump and 8596sc were replaced on (b)(6) 2017.The 8711 was partially removed.The patient was needing escalating doses to achieve effect.They found a tear in the catheter where it passed through 90-degree anchor.The pump segment was replaced and they ¿replaced pump for larger due to dosing.¿ the patient experienced spasticity.There was no patient injury and the patient recovered without sequela.The reason for catheter removal was ¿break, tear, hole.¿ a rotor study was not performed.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Report source was updated/corrected.If information is provided in the future, a supplemental report will be issued.

Event Description

Correction: it was unknown what type of baclofen the patient was receiving.

Manufacturer Narrative

Analysis of the pump found no anomalies.Analysis of the 8711 catheter revealed a hole caused by deep abrasion on the catheter body.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a healthcare provider (hcp) indicated the patient had a fall in (b)(6)2016 and in (b)(6)2016 at a refill, a spinal fluid leak was noted and the patient had significant abdominal pain with spasms and pain at their lumbar incision.Those events occurred at another facility and the nurse did not have further information on the events from that facility.Subsequently, the patient presented to the current facility and was found to have a sub-optimal baclofen dose.The patient's baclofen dose was gradually increased with some, but not significant improvement in their spasms.The pump was noted to be tilted at a 45 degree angle, which was presumed to have been a result of the fall in (b)(6) of 2016, but was still able to be refilled easily.However, they were unable to access the catheter access port on an unspecified date and the patient was taken to surgery on 09-jun-2017 for a pump exploration.As a result of the pump exploration surgery on (b)(6)2017, the pump was replaced with a 40 ml pump and the catheter was revised.The nurse had no additional information regarding that surgical procedure.It was further reported the patient was receiving intrathecal gablofen and the patient's weight was (b)(6).The patient had surgery on (b)(6)2017, which involved baclofen pump replacement and extra spinal catheter revision for partial catheter tear (extra-spinal).The patient was discharged from the hospital on post-operative day 1, after 24 hours in hospital.The patient was increased from initial post-op dosing of 300 mcg/day simple continuous to 360 mcg/day, on post-op day 1.Additional medications the patient was receiving included: oxycodone prn, lorazepam prn, belvig, desonide topical, baclofen oral prn for withdrawal symptoms, tylenol prn, mupirocin topical, percocet scheduled and prn, promethazine, cyancocbalamin, hydrochlorothiazide, potassium chloride, gabapentin, sertraline, methylphenidate, torsemide, methadone, marinol prn.It was noted the patient was not hospitalized after her pump replacement to the hcp¿s knowledge and discharged on post-op day 1.No further complications were reported/anticipated or expected.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6652122
• MDR Text Key: 77914722
• Report Number: 3004209178-2017-13239
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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 Weight: 102