FDA Adverse Event Injury Summary report: N

VERCISE

MDR report key: 10863155 · Received November 18, 2020

Report

Report Number: 3006630150-2020-05652
Event Type: Injury
Date Received: November 18, 2020
Date of Event: September 18, 2020
Report Date: November 18, 2020
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: MHY
UDI-DI: 08714729905196
PMA / PMN Number: P150031
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(4), BATCH: 5180039. THE DBS M8 ADAPTERS DB-9218-15 (SERIAL NUMBERS (B)(4)) WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT WAS NOT CONFIRMED THROUGH DEVICE ANALYSIS. THEREFORE, A PROBABLE CAUSE CANNOT BE DETERMINED AS NO PROBLEM HAS BEEN DETECTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO SWITCH FROM A NON-BSC IMPLANTABLE PULSE GENERATOR (IPG) TO A BSC IPG. DURING THE IMPLANT PROCEDURE, M8 ADAPTORS WERE IMPLANTED TO CONNECT THE EXISTING NON-BSC LEADS TO THE NEW BSC IPG. AN IMPEDANCE CHECK SHOWED APPROPRIATE CONNECTIVITY SO THE CONNECTION WAS SECURED AND THE PATIENT WAS SUTURED. A SECOND IMPEDANCE CHECK SHOWED HIGH IMPEDANCES. THE PHYSICIAN RE-OPENED THE SUB CLAVICULAR POCKET AND REPLACED THE M8 ADAPTORS, HOWEVER, THE HIGH IMPEDANCES REMAINED. THE PHYSICIAN DECIDED TO KEEP THE SYSTEM IMPLANTED AS THEY COULD PROGRAM EFFECTIVE THERAPY USING THE NORMAL IMPEDANCE CONTACTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1329577	VERCISE	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	BOSTON SCIENTIFIC NEUROMODULATION	DB-9218-15	5180037	08714729905196

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention