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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Chest Pain (1776); Dyspnea (1816); Erythema (1840); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling (2091); Tachycardia (2095); Visual Disturbances (2140); Headache, Lumbar Puncture (2186); Distress (2329); Discomfort (2330); Malaise (2359); Impaired Healing (2378); Alteration In Body Temperature (2682); Fluid Discharge (2686); Test Result (2695)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8596sc, serial #: (b)(4), product type: catheter.Product id: 8598a, serial #: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: 31-jan-2021, udi #: (b)(4).Product id: 8598a, serial/lot #: (b)(4), ubd: 28-feb-2021, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a clinical study regarding a patient receiving an unknown drug with an unknown dose and concentration via an implantable pump for no known indication for use.It was reported on (b)(6) 2019 the patient complained of a constant headache.It was noted that the headache increase with change of position.A blood patch was performed on (b)(6) 2019.On (b)(6) 2019 the patient reported headache was 50% better post-procedure, but pain increased again yesterday evening.The patient was going to go to primary care provider (pcp) his afternoon.The clinical diagnosis was spinal headache.The outcome of the event was noted as ongoing.The patient's baseline weight was not measured.The etiology of the event indicated the relationship of the event to the device or therapy was not related and indicated the relationship of the event to the implant procedure was related (surgery/anesthesia).The event date was (b)(6) 2019.No further complications were reported/anticipated.

Manufacturer Narrative

The pump was returned, and analysis found no anomaly of the pump.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(6) 2019.Aspiration of a seroma occurred on (b)(6) 2019.On (b)(6) 2019 the symptoms continued and examination in clinic showed sites were red, warm, and swollen with mild dehiscence and drainage from the spinal site.The patient received intravenous (iv) vanco and oral bactrim before being discharged.On (b)(6) 2019 the hcp received a call from the hospital emergency room (er) and the patient was admitted and not feeling well.A possible infection/possible meningitis infection was noted.The patient's white blood count (wbc) was 14.On (b)(6) 2019 laboratory testing found no growth/cultures in pump pocket site and cerebrospinal fluid (csf) had grown staph.It was indicated the patient had meningitis.The event resulted in/required in patient or prolonged hospitalization.The entire system was explanted/not replaced on (b)(6) 2019.No further complications were reported/anticipated.

Manufacturer Narrative

Updated to reflect the information received on 2019-may-15.Updated to reflect the device received on 2019-may-08.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider (hcp) via a clinical study on 2019-may-15.It was reported that, as of (b)(6) 2019, the patient was receiving 1000 mcg of fentanyl at 400.28232 mcg/day and 10 mg of bupivacaine at 4.00282 mg/day.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated the outcome of the event was unresolved at time of study exit/death/study closure.Additional information received from a healthcare professional (hcp) via a clinical study indicated the outcome was study exit.No further complications were reported/anticipated.No further complications were reported/anticipated.

Manufacturer Narrative

Continuation of d11: product id 8596sc serial# (b)(4).Product type catheter product id 8598a serial# (b)(4).Product type catheter h6- additional patient codes: c3303 c50921 c26828 c34661 c3038 c50664 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.

Event Description

Information was received from a healthcare professional via a clinical study regarding a patient receiving dilaudid with an unknown dose and concentration, bupivacaine unknown dose and concentration, and fentanyl with an unknown dose and concentration via an implantable pump for non-malignant pain and chest wall.It was reported on 2019-apr-22 examination revealed redness and poor wound healing at the pump pocket implant site with evidence of fluid collection over the site.On 2019-apr-22 medical or non-surgical therapy was performed where aspiration of the pump pocket site was performed and samples were sent.The clinical diagnosis was fluid collection over pocket site.The outcome of the event was noted as ongoing.The patient's baseline weight was not measured.The event date was (b)(6) 2019.The etiology of the event indicated the relationship of the event to the device or therapy was not related and indicated the relationship of the event to the implant procedure was related.No further complications were reported/anticipated.Information was received from a healthcare provider (hcp) via a device manufacturer representative (rep).The device was being used to deliver 1,000 mcg/ml fentanyl at 400.3 mcg/day, and 10 mg/ml bupivacaine at 4.003 mg/day.They indicated there was a concern for a potential, partially treated meningitis given her headache, subjective fevers, and neck stiffness.A lumbar puncture demonstrated 14 white blood cell (wbc).It was noted that could be skewed given she had had doses of vancomycin and bactrim and had a recent blood patch.Computerized tomography (ct) imaging of the head and chest were unremarkable.The remainder of the laboratory work up was unremarkable.There appeared to be erythema around the site of her pain pump and the hcp was considering the removal of the pump at that time.The patient was admitted for further evaluation and treatment.The diagnosis at that time was postoperative infection of an unspecified type and meningitis after procedure.Evaluation on admission found no rigidity, the trachea was in the midline, and there was discomfort with flexion and extension.A cardiovascular evaluation found regular rhythm, tachycardic, and no murmur.A respiratory evaluation indicated the breath sounds were clear bilaterally, non-labored, and no retractions or accessory muscle use.A gastrointestinal evaluation found the abdomen was soft, no distension and no tenderness.The skin was warm and dry with no rash or lesions noted.The incision in the right buttock had surrounding erythema and tenderness.A psych evaluation found the patient awake, alert, normal affect, and appropriate interactions.A review of systems found visual disturbances (occasional double vision), shortness of breath, chest pain, and leg swelling.The patient's blood pressure was 152/92.A physical exam revealed the patient was alert, interactive in mild distress.It was further noted the patient had redness around the pain pump and pain associated with it.The patient followed up with the implanting physician and the site was aspirated but she continued to have symptoms.The patient had a blood patch procedure, but no relief.The patient was currently on bactrim and had had two doses of vancomycin.The patient noted having a headache and neck pain that had been present for the past two days prior to (b)(6) 2019.The patient additionally noted chest pain and shortness of breath.It was further noted the patient had developed a seroma and ultimately meningitis.The patient had been hospitalized and cultures from the cerebrospinal fluid (csf) had grown out staph.The pump and catheter were explanted from the patient on (b)(6) 2019.The product was returned to the manufacturer for analysis.Concomitant medications were listed as midazolam for allergies, and other medications included albuterol, armodafani, catapres, cymbalta, gabapentin, hydrochlorothiazide, hydroxyzine, morphine, zantac, and bactrim.There were no further complications reported/anticipated.

• 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
• MDR Report Key: 8563287
• MDR Text Key: 143535997
• Report Number: 3004209178-2019-08557
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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,Followup,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 43 YR