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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Battery Problem (2885)

Patient Problems Dehydration (1807); Fever (1858); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Tachycardia (2095); Therapeutic Response, Decreased (2271); Irritability (2421); Sweating (2444); Diaphoresis (2452); No Known Impact Or Consequence To Patient (2692); Test Result (2695); No Code Available (3191); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional and a manufacturer representative regarding a patient receiving an unknown baclofen with an unknown dose and concentration via an implantable pump for no known indication for use.It was reported the patient experienced a dead battery and later found out that there had been a recall on battery life that they have not been informed of.They demanded the pump be explanted.It was unknown how far into the 2 years it was when the pump's battery went dead.It was noted that the pump was explanted and the patient remains minimally conscious.No symptoms were reported.Event date was unknown.No further complications were reported/anticipated.

Manufacturer Narrative

The other relevant components include: product id neu_unknown_cath serial# unknown product type catheter patient code (b)(4) is in reference to the reported "autonomic storming/neurostorming." if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a business partner on 2018-jan-26.It was reported that the patient's medical history included a traumatic brain injury (tbi).The patient was further identified as a (b)(6) caucasian at the time of the events.Additional medical history included further description of indication for intrathecal baclofen use: following the tbi, the patient "started in a coma, went into a vegetative state and then finally to his current state of minimal consciousness, where he has plateaued," contractures in ankles and feet, increased tone, spasticity, and dystonia.On (b)(6)2008, the patient started treatment with baclofen with "dosing/baclofen pump settings" noted as follows by patient's mother (unable to discern from report if dosing is concentration or daily dosing as units were not provided): (b)(6)2008: 200, (b)(6)2008: 400, (b)(6)2008: 600, (b)(6)2008: 800 ["physician not impressed with effect, and was concerned about sedation with high dosage"], (b)(6)2008: 600, (b)(6)2008: 500, [patient's left leg raised and extended for first time on (b)(6)2018; presumed to be positive effect of itb treatment], (b)(6)2008: 400 ["first noted left leg rolling out atthe hip on (b)(6)2008" presumed to be positive effect of itb treatment], (b)(6)2008: 480, (b)(6)2008: 504, (b)(6)2008: 504, (b)(6)2009: 554 ["physician increasing pump to see the (effect"], (b)(6)2009: 610, and (b)(6)2009: 676.On an unspecified date in (b)(6)2009, sometime prior to (b)(6)2009, the patients "therapy" included vital-stim therapy 3 days/week, bioness therapy on hands 2 days/week, and pool therapy (first session on (b)(6)2009).On an unspecified date, the patient had to have two surgeries to lengthen the tendons (presumed to be due to continued contractures in his legs and feet).From (b)(6)2009, the patient's tone was described as "very loose, both legs bending easily, neck very easy to do rom (range of motion)." from (b)(6)2009, the patient had periods of agitation, diaphoresis, increased tone, and moaning heavily.The symptoms would subside after 10-30 minutes after given calms forte with good results.On (b)(6)2009, at 1:00 a.M.The patient was agitated, d diaphoretic (bedding soaked, changed several times), heart rate (hr) was 118, and temperature was 97.At 5:00 a.M., hr was 187, blood pressure (bp) was 187/117, he was stiff, and diaphoretic.Ativan (lorazepam) 1 mg was given with no effect.Temperature was 99.5 at 6:30 a.M.The patient's mother contacted the patient's physiatrist and was told to go to the hospital for "possible itb withdrawal, all symptoms consistent with itb withdrawal." the patient was taken to emergency room (er) via ambulance.En route, intravenous (iv) fluids were administered along with versed (midazolam), temperature was 101.At the er, temperature was 103.Infection disease was consulted, and the patient was covered for possible strep or pool infection, and was given vancomycin, rocephin (ceftriaxone), and fortaz (ceftazidime).A cooling blanket was put on the patient, and ice packs placed under his arms.Unspecified labs were taken (showed no bacteria), and electroencephalography (eeg; results not reported) and computerized tomography (ct) scan (results not reported) were performed.White blood cell count (wbc) was elevated at "25." x-rays and diagnostics "cleared the itb as malfunctioning." at 2:00 p.M., the patient was in the intensive care unit (icu).The baclofen pump was checked with an interrogator by the physician., who declined to check the catheter port ("[the manufacturer's] literature said to do so"; full diagnostics not done as requested).Oral baclofen 50 mg was given as a precaution.Catheter insertion (presumed urinary catheterization) was attempted, but was unable to be completed due to patient's agitation.The patient's final diagnosis was noted as "viral or autonomic storming response." on (b)(6)2009, the patient was discharged.On (b)(6)2009, the patient experienced agitation, along with diaphoresis and stiffness, which occurred in "periods of every day at least once, sometimes 2-3 times a day." the patient's tone was also increased while awake and engaged, and was very hard to change and transfer.His tone decreased while asleep.(b)(6)2009 the patient's baclofen dosing was "700." on (b)(6)2009 at 2:00 a.M.The patient was diaphoretic, agitated and stiff.At 3:30 a.M.His hr was 162 and temperature was 99.At 7:30 a.M.His temperature was 102.5 and hr was 175.The patient's mother contacted his physiatrist and was directed to go to the er for "possible withdrawal." an ambulance was called, and en route the patient was given iv fluids and versed.At the er, the patient's temperature was 105.Wbc count was elevated.The patient was dehydrated and given iv fluids.Testing included unspecified labs, eeg, and ct scan of the head (results not reported).The pump was checked by the treating physician; x-rays and diagnostics "cleared itb as malfunctioning" ("but all diagnostics not done"; patient's mother also reported "pump was failing").The physiatrist recommended checking the catheter port of pump for presence/absence of drug, but the treating physician "said it would not prove anything," and he lifted up the patient's leg to show the tone was not present.The interrogator indicated the pump was fine, and he refused to do the catheter diagnostics indicated by the manufacturer's literature.Urinary catheterization was attempted and it was found that there was a stricture in the urethra and bladder residuals.The "urologist used a scope to see the stricture, and it was cleared in surgery." the patient's final diagnosis was noted as "urinary stricture caused autonomic storming." on (b)(6)2009, the patient was discharged, with instructions to use a straight catheter (fr.14) twice a week until the patient could be seen by a urologist at home.On (b)(6)2009, the patient again experienced diaphoresis and stiffness.Periods of this occurred every day, at least once, sometimes 2-3 times a day.The periods grew more intense every day, and he had six episodes on (b)(6)2009.He also had increased tone while awake and engaged (very hard to transfer and change), and his tone would decrease when he was asleep.On (b)(6)2009, at 12:30 a.M., the patient's bed was soaked with sweat, and he was moaning loudly.The patient's mother gave him tylenol (acetaminophen).At 7:00 a.M., his legs were stiff, his arms were waving, hands were clenched, and his nails were digging into his palms.At 8:00 a.M., his hr was 123.He was given more tylenol and ativan, and his mother was wiping his face every 5 minutes.The patient's mother contacted the patient's physiatrist and was advised to get oral baclofen and go to the hospital.At 10:00 a.M., oral baclofen was picked up from the pharmacy, and the patient was given 20 mg.At 10:30 a.M., his hr was 135 and axillary temperature was 100.At 12:00, the ambulance came, and iv fluids, versed, and 10 mg oral baclofen were administered.In the er, the treating physician's assistant checked the pump, including the side catheter, and found that there was no drug in the catheter.Itb withdrawal was suspected.The "same testing" as at the last hospital visit were performed (records from previous hospitalization were faxed over for comparison); wbc was elevated (exact measurement not reported).The patient was admitted to the icu, he was diaphoretic, hr was elevate d.On (b)(6)2009, the pump replaced and the dose was set at "700".The patient was then sent back to the icu for observation and his breathing was noted to be irregular.The patient's final diagnosis was noted as "itb malfunction, triggering neurostorming." on 20 (b)(6)2009, the patient was discharged to home with intrathecal baclofen dosing at "1028" (dosing also noted to be reset to "1026.9" on (b)(6)2009).At discharge, it was noted that the patient's forehead was sweaty, chest rattly, eyes rolling around with eyelids open, and he was very lethargic.When he got home he was put to bed, then was up in a chair at 7:00 p.M.He was calm and was breathing easier.At 7:45 p.M., after being home for 5 hours since discharge, the patient had a grand mal seizure, during which his legs and arms were stiff and moving, his eyes were blinking very quickly and his face was contorted.The patient's physiatrist was contacted and 911 was called.His temperature was 101 and hr was 175.The family put in a bite block while waited for the ambulance.At 8:05 a.M., the ambulance arrived, and the patient was still seizing.Emt was not able to get iv line in for versed, so they administered 4 mg directly into the patient tibial bone marrow via a power drill.The seizure stopped.At 8:45 p.M., the ambulance left for the hospital "code 3," and iv fluids were given en route.At the er, unspecified testing was performed; wbc was elevated (specific meas measurement not reported) and temperature was 103.He was admitted to the icu and stabilized.His breathing was irregular and he was still diaphoretic.A lumbar "punch" (presumed puncture) was performed under fluoroscopy to rule out meningitis.The patient's final diagnosis was noted as "acinetobacter bacteria in the chest." a peripherally inserted central catheter (picc) line was needed for tobramycin treatment.Medication changes included addition of keppra (levetiracetam) to prevent seizures, metoprolol "in half," and effex or(venlafaxine hcl) was to be decreased and discontinued.On (b)(6)2009, the patient was discharged.[the information regarding the loss of therapy and catheter occlusion originally reported in mfg.Report # 3007566237-2017-05068 will now be reported under this mfg.Report #].

Manufacturer Narrative

Continuation of d10: product id neu_unknown_cath lot# serial# unknown product type catheter h3: the pump was returned, and analysis found end of service due to time progression.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 7085654
• MDR Text Key: 93805122
• Report Number: 3004209178-2017-24913
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2009
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention