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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BATTERY BONE STIMULATOR/ LEADS, WIRES; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN
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BATTERY BONE STIMULATOR/ LEADS, WIRES; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN Back to Search Results
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problems Death (1802); Pain (1994); Malaise (2359)
Event Date 07/08/2013
Event Type  Injury  
Event Description
Auto accident spinal surgery (b)(6) 2013.I and others were given a contaminated drug at the (b)(6), called calcium gluconate.People died/ i nearly died.But during my back surgery, the surgeon, dr.(b)(6) had cut into a set of battery bone stimulator wires, that have been left in my spine and causing me severe health and chronic pain for over 23 yrs.The surgeons who intentionally left them in me were (b)(6), dr (b)(6) and a surgeon who i nicknamed dr.(b)(6).I am still very, very sick and with the wires fused into my spine.A (b)(6) medical surgeon needed a mri from me, but their x- ray dept refused to do me the mri because of the dangers involved to my health [wires].Mfr: metronic/not sure.
 
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Brand Name
BATTERY BONE STIMULATOR/ LEADS, WIRES
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN
MDR Report Key7952062
MDR Text Key123559342
Report NumberMW5080447
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/1994
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age54 YR
Patient Weight91
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