UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Report

Report Number: 3007566237-2018-01924
Event Type: Malfunction
Date Received: June 28, 2018
Date of Event: May 1, 2018
Report Date: June 28, 2018
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SASAKI, T., AGARI, T., KUWAHARA, K, KIN, I., OKAZAKI, M., SASADA, S., SHINKO, A., KAMEDA, M., YASUHARA, T., DATE, I. EFFICACY OF DURAL SEALANT SYSTEM FOR PREVENTING BRAIN SHIFT AND IMPROVING ACCURACY IN DEEP BRAIN STIMULATION SURGERY. NEUROL MED CHIR (TOKYO). 2018;58(5):199-205. DOI: 10.2176/NMC.OA.2017-0242. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

SUMMARY: THE SUCCESS OF DEEP BRAIN STIMULATION (DBS) DEPENDS HEAVILY ON SURGICAL ACCURACY, AND BRAIN SHIFT IS RECOGNIZED AS A SIGNIFICANT FACTOR INFLUENCING ACCURACY. WE INVESTIGATED THE FACTORS ASSOCIATED WITH SURGICAL ACCURACY AND SHOWED THE EFFECTIVENESS OF A DURAL SEALANT SYSTEM FOR PREVENTING BRAIN SHIFT IN 32 CONSECUTIVE CASES RECEIVING DBS. THIRTY-TWO PATIENTS RECEIVING DBS BETWEEN MARCH 2014 AND MAY 2015 WERE INCLUDED IN THIS STUDY. WE EMPLOYED CONVENTIONAL BURR HOLE TECHNIQUES FOR THE FIRST 18 CASES (GROUP I) AND A DURAL SEALANT SYSTEM (DURASEAL) FOR THE SUBSEQUENT 14 CASES (GROUP II). WE MEASURED GAPS BETWEEN THE ACTUAL POSITIONS OF ELECTRODES AND THE PREDETERMINED TARGET POSITIONS. WE THEN RETROSPECTIVELY EVALUATED THE FACTORS INVOLVED IN SURGICAL ACCURACY. THE AVERAGE GAP BETWEEN AN ELECTRODE¿S ACTUAL AND TARGET POSITIONS WAS 1.55 ± 0.83 MM IN ALL CASES. POSTOPERATIVE SUBDURAL AIR VOLUME E, THE ONLY FACTOR ASSOCIATED WITH SURGICAL ACCURACY (R = 0.536, P <(><<)> 0.0001), WAS SIGNIFICANTLY SMALLER IN GROUP II (GROUP I: 43.9 ± 27.7, GROUP II: 12.1 ± 12.5 ML, P = 0.0006). THE AVERAGE ELECTRODE POSITION GAP WAS ALSO SIGNIFICANTLY SMALLER IN GROUP II (GROUP I: 1.77 ± 0.91, GROUP II: 1.27 ± 0.59 MM, P = 0.035). USE OF A DURAL SEALANT SYSTEM COULD SIGNIFICANTLY REDUCE INTRACRANIAL AIR VOLUME, WHICH SHOULD IMPROVE SURGICAL ACCURACY. REPORTED EVENTS: THE AUTHORS REPORTED THAT THE AVERAGE GAP BETWEEN ELECTRODES AND THE PREOPERATIVELY DEFINED OPTIMAL TARGETS WAS 1.27 ± 0.59 MM. THE POSTOPERATIVE SUBDURAL AIR VOLUME WAS THE ONLY FACTOR THAT WAS SIGNIFICANTLY ASSOCIATED WITH SURGICAL ACCURACY. THE AUTHORS RELATED THIS TO THE BRAIN SHIFT (¿POSTERIOR SHIFT OF THE ANTERIOR COMMISSURE-POSTERIOR COMMISSURE LINE IN BILATERAL SURGERY¿) CAUSED BY INTRACRANIAL AIR INVASION (R = 0.536). THE AUTHORS NOTED THAT THEIR STUDY RESULTS WERE CONSISTENT WITH THOSE OF PREVIOUS REPORTS WHEREIN, WITH THE DISAPPEARANCE OF THE SUBDURAL AIR THE ELECTRODE WOULD MOVE UPWARD ALONG THE IMPLANT TRAJECTORY. IN ADDITION, THEY STATED THAT ONCE THE BRAIN HAD SHIFTED DUE TO INVASION OF INTRACRANIAL AIR DURING LEAD IMPLANT SURGERY ELECTRODE PLACEMENT AT THE INTENDED POSITION BECAME DIFFICULT. THE MEASURED POSTOPERATIVE SUBDURAL AIR VOLUME RANGED BETWEEN 0 AND APPROXIMATELY 90 MILLILITERS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
489403	UNKNOWN IMPLANTABLE NEUROSTIMULATOR	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC NEUROMODULATION	NEU_INS_STIMULATOR	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR