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

Model Number 8637-20

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

Patient Problems Anemia (1706); Cellulitis (1768); Erythema (1840); Headache (1880); Hematoma (1884); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Nausea (1970); Pain (1994); Rash (2033); Seroma (2069); Swelling (2091); Vomiting (2144); Discomfort (2330); Fluid Discharge (2686); Test Result (2695)

Event Date 07/05/2018

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 provider via a clinical study regarding a patient receiving dilaudid, bupivacaine, and clonidine via an implanted pump. The indication for use was non-malignant pain. It was reported the patient had a pump refill on (b)(6) 2018 and there was no emr progress note describing a pocket infection however bactrim ds tablet 800-160 mg and sig: 1 po bid x 3 days were prescribed. The patient went to the office, on (b)(6) 2018, complaining of redness, swelling and pain at pocket site. The patient stated the symptoms had started a week ago. A ct scan with contrast was performed and there was a suspected 4. 3 x 2. 2 x 1. 2cm fluid collection/abscess on abdominal pocket. The clinical diagnosis was pocket infection. The physician examined the patient and immediately admitted the patient to the hospital for testing. Laboratory testing was performed on (b)(6) 2018 but the test results were not present in the emr at the time of report. The hospital aspirated the pump pocket fluid for culture on (b)(6) 2018. Infectious disease was consulted and the patient was prescribed vancomycin. It was indicated the event was possibly related to the device or therapy. The patient was discharged on (b)(6) 2018 and was to return to the office on (b)(6) 2018. The issue required in-patient or prolonged hospitalization. It was noted the event was ongoing.

Manufacturer Narrative

Updated to reflect the patient's baseline weight received on 2018-oct-08. Updated to reflect the information received on 2018-oct-08. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider (hcp) via a clinical study on 2018-oct-08. The cause of the pocket infection was unknown. Medications were reportedly given to the patient on (b)(6) 2018 and on (b)(6) 2018. The pocket fluid was evacuated on (b)(6) 2018. The event was considered ongoing as of 2018-aug-15. The patient's baseline weight was provided. 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 provider via a clinical study reported the patient had cellulitis. It was noted the patient had a large, tender rash over their right flank, weeks prior. The clinical diagnosis was neurostimulator device pocket hematoma and intractable, hyperglycemia and htn urgency. It was then clarified to pump pocket hematoma and tractable. There was a small mildly complex fluid seen overlying the stimulator measuring 5. 4x6. 6x1. 4cm, suggestive of a small hematoma on (b)(6) 2018. Laboratory testing was performed an creatine serum was high at 1. 23 and hemoglobin was low at 10. 6. The patient was admitted to the hospital, where the pocket was drained and the patient was put on antibiotics. The patient was given an increased insulin dose and received alp under fluro which showed a bloody tap, likely the hematoma was tracking into the csf. Three days after the patient was discharged the patient developed a headache, nausea, and vomiting associated with uncontrolled hyperglycemia and elevated blood pressure. It was indicated the event was possibly related to the device or therapy. The issue resulted in in-patient hospitalization. The issue resolved without sequelae on (b)(6) 2018.

Manufacturer Narrative

Updated to reflect the information received on (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a clinical study on (b)(6) 2018. It was reported that, at the time of the event, the patient was receiving 12 mg/ml of bupivacaine at 1. 31987 mg/day, 250 mcg/ml of clonidine at 27. 49731 mcg/day, and 2. 5 mg/ml of dilaudid at 0. 27497 mg/day via simple continuous infusion. No further complications were reported or 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
• 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: 7788778
• MDR Text Key: 117287735
• Report Number: 3004209178-2018-18387
• Device Sequence Number: 1
• Product Code: LKK
• 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: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2019
• 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: 04/19/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/10/2017
• 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: 08/16/2018 Patient Sequence Number: 1