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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problems Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Neuropathy (1983); Pain (1994); No Code Available (3191)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported that the patient was having pain at the ipg site due to excessive weight loss from a non device related surgery.The physician believed that the pain was due to the placement of the ipg.The patient was also suffering from nerve damage and neuropathy.
 
Event Description
It was reported that the patient was having pain at the ipg site due to excessive weight loss from a non device related surgery.The physician believed that the pain was due to the placement of the ipg.The patient was also suffering from nerve damage and neuropathy.The patient was looking forward for an explant.Additional information was received that the patients ipg was non functional.The patient underwent an ipg replacement procedure wherein an mri compatible ipg was implanted and was doing well.Explanted ipg will not be returned.
 
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Brand Name
PRECISION SPECTRA
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 Key10808083
MDR Text Key215258352
Report Number3006630150-2020-05415
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
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 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/19/2017
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number18285557
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
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