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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 High impedance (1291); Delayed Charge Time (2586); Charging Problem (2892)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2023
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads upn: m365sc2317500, model: sc-2317-50, serial: (b)(6), batch: 19085047.
 
Event Description
It was reported that the patient was frequently charging the ipg for an extended period of time.It was also noted that the leads had high impedances.The patient underwent a revision procedure wherein the ipg and leads were replaced.The patient was doing well postoperatively.The explanted devices will not be returned per facility policy.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key18833187
MDR Text Key336858518
Report Number3006630150-2024-01179
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/04/2024
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 Date04/14/2018
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number19132900
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2016
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;
Patient Age67 YR
Patient SexFemale
Patient Weight104 KG
Patient RaceWhite
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