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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION NOVI; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION NOVI; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2408-56
Device Problems High impedance (1291); Kinked (1339); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2017
Event Type  Injury  
Event Description
A report was received that during an implant procedure, the physician noticed a kink on the tuohy needle after it was removed.The physician also noticed high impedances a contact missing on the lead where it connects to the external trial system.The missing contact was not recovered and a new lead was implanted into the patient.The patient is doing well post operatively.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: model # 6045771-104, lot # 5001962104, description: 4 inch insertion needle additional information was received that the lead with the missing contact was not inside the patients body.
 
Event Description
A report was received that during an implant procedure, the physician noticed a kink on the tuohy needle after it was removed.The physician also observed high impedances and a contact missing on the lead where it connects to the external trial system.The missing contact was not recovered and a new lead was implanted into the patient.The patient is doing well post operatively.
 
Manufacturer Narrative
(b)(4) device analysis of the lead revealed that the complaint was confirmed.Visual inspection found that the lead proximal end was fractured and contact # 7 was removed and it is not returned.Cable is exposed at the fractured portion of the proximal end.Damage most likely occurred when the damaged needle (bent tip) was pulled off the lead during the procedure.Resistance on the lead body and proximal contacts were felt when technician attempted to insert and remove the lead from the needle.(b)(4) device analysis of the insertion needle revealed that the complaint has been confirmed.Visual inspection showed the tip of the needle bent and damaged.
 
Event Description
A report was received that during an implant procedure, the physician noticed a kink on the tuohy needle after it was removed.The physician also observed high impedances and a contact missing on the lead where it connects to the external trial system.The missing contact was not recovered and a new lead was implanted into the patient.The patient is doing well post operatively.
 
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Brand Name
PRECISION NOVI
Type of Device
SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key6775392
MDR Text Key82108079
Report Number3006630150-2017-02852
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729904816
UDI-Public08714729904816
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/12/2017
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 Physician
Device Expiration Date11/02/2018
Device Model NumberSC-2408-56
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2017
Initial Date FDA Received08/08/2017
Supplement Dates Manufacturer Received09/29/2017
10/24/2017
Supplement Dates FDA Received10/03/2017
10/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2016
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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