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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1232
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Seroma (2069); Implant Pain (4561)
Event Date 08/08/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs- paddle leads, upn: m365sc8336500, model: sc-8336-50, serial: (b)(4), batch: 7074608.
 
Event Description
It was reported that the patient was having sudden onset of extreme pain and hypersensitivity at the ipg site.The patient underwent a procedure wherein upon opening of the ipg pocket, it was discovered that there was a cloudy fluid surrounding the ipg, and the ipg was explanted.The midline incision was opened and the lead tails were cut just below the anchor site.The lead tails were then pulled back through the ipg pocket and removed.The paddle portion of the lead was left in the epidural space in hope that the system can be replaced after the suspected infection clears.The patient was placed on antibiotics, and the explanted ipg was discarded.
 
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Brand Name
WAVEWRITER ALPHA
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12422168
MDR Text Key269788213
Report Number3006630150-2021-04943
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729985099
UDI-Public08714729985099
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/03/2021
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? No
Device Operator Lay User/Patient
Device Expiration Date06/15/2023
Device Model NumberSC-1232
Device Catalogue NumberSC-1232
Device Lot Number514045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2021
Initial Date FDA Received09/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2021
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;
Patient Age42 YR
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