MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-45

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

Patient Problems Abscess (1690); Death (1802); Edema (1820); Granuloma (1876); Hemorrhage, Cerebral (1889); Unspecified Infection (1930); Seizures (2063); Encephalitis (2429); No Code Available (3191)

Event Date 01/14/2019

Event Type  Death  

Manufacturer Narrative

Date of birth: (b)(6); exact date of birth is unknown.It is indicated that the lead db-2202-45 (serial number: (b)(4)) will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.Additional suspect medical device components involved in the event: model: db-2202-45, serial/lot: (b)(4), description: dbs directional lead sterile kit 45cm.Model: nm-3138-55, serial/lot: (b)(4), description: 55cm 8 contact extension.Model: nm-3138-55, serial/lot: (b)(4), description: 55cm 8 contact extension.Model: db-1140, serial/lot: (b)(4), description: vercise primary cell ipg.The four additional devices are not expected to be returned as they remain implanted in the patient; therefore a technical product analysis cannot be carried out.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

A report was received that a dbs patient was admitted to the hospital after a follow-up head ct showed an abscess of the left cerebral hemisphere and granuloma in the spinal canal and cord.Upon admission, the patient was conscious with impaired logic and verbal responsiveness.The patient was lying down and did not open his eyes on command.The patient was treated with dexaven for epilepsy seizure.The patient then underwent an explant procedure the following day to remove the left lead and aspiration of the left hemisphere abscess.The lead was sent for microbiological testing, blood was collected for culture, and urine cultures were negative.Based on clinical and radiological indications for encephalitis, the patient was started on biotaxim, metronidazole, vancomycin, and ampicillin.The patient was administered a pharmacological block and connected to a ventilator.The next day, a head ct showed extensive cerebral edema or inflammatory infiltration of the left cerebral hemisphere.Also, in the center of the edema, there was visible hemorrhagic and fluid spaces.The physician noted there was evidence of cerebral mass effect with herniation under falx cerebelli on the right side.The patients health continued to deteriorate and neurological examination revealed progression of encephalopathy and brain stem damage.The patient passed away two days later.The physician assessed that this event has a probable relationship to the procedure and hardware, but was not related to device stimulation.

Manufacturer Narrative

Additional information was received that the lead that was sent for microbiological testing revealed serratia marcescens.

Event Description

A report was received that a dbs patient was admitted to the hospital after a follow-up head ct showed an abscess of the left cerebral hemisphere and granuloma in the spinal canal and cord.Upon admission, the patient was conscious with impaired logic and verbal responsiveness.The patient was lying down and did not open his eyes on command.The patient was treated with dexaven for epilepsy seizure.The patient then underwent an explant procedure the following day to remove the left lead and aspiration of the left hemisphere abscess.The lead was sent for microbiological testing, blood was collected for culture, and urine cultures were negative.Based on clinical and radiological indications for encephalitis, the patient was started on biotaxim, metronidazole, vancomycin, and ampicillin.The patient was administered a pharmacological block and connected to a ventilator.The next day, a head ct showed extensive cerebral edema or inflammatory infiltration of the left cerebral hemisphere.Also, in the center of the edema, there was visible hemorrhagic and fluid spaces.The physician noted there was evidence of cerebral mass effect with herniation under falx cerebelli on the right side.The patients health continued to deteriorate and neurological examination revealed progression of encephalopathy and brain stem damage.The patient passed away two days later.The physician assessed that this event has a probable relationship to the procedure and hardware, but was not related to device stimulation.

• Brand Name: VERCISE CARTESIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8507157
• MDR Text Key: 141717961
• Report Number: 3006630150-2019-01647
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/2020
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5038302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death