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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION 95CM, 2X8 CONTACT LEAD EXTENSION KIT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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BOSTON SCIENTIFIC NEUROMODULATION 95CM, 2X8 CONTACT LEAD EXTENSION KIT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-3128-95
Device Problems High impedance (1291); Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2022
Event Type  Injury  
Event Description
It was reported that during a routine follow up procedure high impedances were noted on several contacts of the lead.A revision procedure was performed.During the revision procedure, the surgeon was unable to remove the lead from the lead extension the lead extension set screw was completely backed out and when the lead was pulled on, contact 8 was stuck inside the lead extension header.The physician explanted the lead extension and decided to cut the lead because it became damaged during removal.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(4), batch: 7070164.
 
Manufacturer Narrative
The explanted lead and lead extension were returned and analyzed.The complaint of the lead being stuck inside the lead extension header was confirmed.Visual inspection showed severe damage to the lead extension connector.Both the gold and silver connector block of the lead extension were removed.The silver connector block was stuck on the returned lead's proximal end and one spring contact was also removed and not returned (it was confirmed that the missing spring contact was not left inside the patient).The lead was found to not be fully inserted into the lead extension which caused the lead extension set screw to crush the lead's proximal array in between it's contacts.This caused mis-alignment of the contacts and resulted in high impedances.The most probable cause of the reported event is unintended user error caused or contributed to the event.
 
Event Description
It was reported that during a routine follow up procedure high impedances were noted on several contacts of the lead.A revision procedure was performed.During the revision procedure, the surgeon was unable to remove the lead from the lead extension the lead extension set screw was completely backed out and when the lead was pulled on, contact 8 was stuck inside the lead extension header.The physician explanted the lead extension and decided to cut the lead because it became damaged during removal.
 
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Brand Name
95CM, 2X8 CONTACT LEAD EXTENSION KIT
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key14374655
MDR Text Key291499127
Report Number3006630150-2022-02193
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/21/2023
Device Model NumberDB-3128-95
Device Catalogue NumberDB-3128-95
Device Lot Number5000503
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2022
Initial Date FDA Received05/12/2022
Supplement Dates Manufacturer Received08/05/2022
Supplement Dates FDA Received08/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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