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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2316-50E
Device Problems Fracture (1260); Difficult to Remove (1528); Use of Device Problem (1670); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 01/31/2020
Event Type  malfunction  
Event Description
A report was received that during the trial procedure, the lead was difficult to position and got stuck into the epidural space and was hitting resistance.The physician kept trying to remove it until the lead broke after the fifth contact and completely separated from the rest of the lead.It was also reported that the remaining fragment of the lead was removed.The patient was doing well post operatively.
 
Manufacturer Narrative
Device evaluation indicated that the complaint damage of the lead has been confirmed.Visual inspection revealed that the top five electrodes are separated from the distal end.Electrodes 1-5 were not returned.The cables are exposed at the damaged portion of the lead.This kind of anomaly is consistent with the damages done to a lead when the orientation of the insertion needles bevel is facing down, or the angle of the insertion needle is greater than 45 degrees.An angle of more than 45 degrees increases the risk of lead damage.Dfu states that use only an insertion needle provided by boston scientific.Other needles may damage the lead.The number 14 on the needle hub corresponds to the orientation of the bevel, which must face up.Turning the bevel ventral down may result in lead damage.An angle of more than 45 degrees increases the risk of lead damage.The probable cause selected is unintended use error caused or contributed to event.
 
Event Description
A report was received that during the trial procedure, the lead was difficult to position and got stuck into the epidural space and was hitting resistance.The physician kept trying to remove it until the lead broke after the fifth contact and completely separated from the rest of the lead.It was also reported that the remaining fragment of the lead was removed.The patient was doing well post operatively.
 
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Brand Name
INFINION 16
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key9731281
MDR Text Key180130101
Report Number3006630150-2020-00687
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797807
UDI-Public08714729797807
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/31/2020
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 Date10/22/2021
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number7071923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Initial Date Manufacturer Received 01/31/2020
Initial Date FDA Received02/20/2020
Supplement Dates Manufacturer Received03/11/2020
Supplement Dates FDA Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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